Recall Notice Research Articles

Adverse events associated with anastomotic coupling devices in microvascular reconstruction

ObjectiveIn light of the recent US Food and Drug Administration (FDA) Class 2 safety recall notice for anastomotic coupling devices, it is important to understand related adverse events. The aim of this study was to characterize adverse events in anastomotic coupling devices for microvascular reconstruction. MethodsA retrospective cross-sectional analysis using the 2011 to 2021 US FDA Manufacturer and User Facility Device Experience (MAUDE) database. All reports of adverse events involving anastomotic coupling devices were retrieved from the MAUDE database. Descriptive statistics were used to analyze categorized events. ResultsThere were a total of 293 documented adverse events related to anastomotic coupling devices. These adverse events resulted in 91 (31.1 %) patient injuries and 239 (81.6 %) device malfunctions. The most frequent patient problems were thrombosis/hematoma (n = 38; 41.8 %), unspecified injury (n = 31; 34.1 %), and failure to anastomose (n = 13; 14.3 %). Free flap necrosis was reported in 42 % of thrombosis/hematoma cases (n = 16). The most common malfunctions were devices operating differently than expected (n = 74; 31.0 %), connection problems (n = 41; 17.2 %), and twisted/bent material (n = 19; 7.9 %). There was no significant trend in the number of adverse events over the study period (p > 0.05). ConclusionsAdverse events from anastomotic coupling devices represent an important and modifiable factor in free tissue failure. Adverse events are predominately related to devices operating differently than expected and may result in vascular compromise of the free flap. Reconstructive surgeons should be cognizant of defective anastomotic coupling devices and be prepared to utilize traditional hand-sewn anastomosis.

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study.

Medical device recalls are initiated in response to safety concerns. Class I (highest severity) recalls imply a reasonable likelihood of serious adverse events or death associated with device use. Recalled devices must be identified, assessed, and corrected or removed, upon which a recall can be terminated. To characterize Class I medical device recalls and corresponding recalled devices. This was a cross-sectional study of Class I recalls posted on the Food and Drug Administration's annual log from January 1, 2018 to June 30, 2022 for moderate-risk and high-risk medical devices. Devices were categorized by therapeutic use, need for implantation, and life-sustaining designation; recalls were categorized by reason, status, and time elapsed. There were 189 unique Class I medical device recalls, including 151 (79.9%) for moderate-risk and 34 (18.0%) for high-risk devices. Sixty-five (34.4%) recalls were for cardiovascular devices, 36 (19.0%) for implanted devices, and 37 (19.6%) for life-sustaining devices. The median number of device units recalled in the US per recall notice was 4620 (interquartile range [IQR], 578-42,591), with 11 (5.8%) recalls associated with more than 1 million device units. Overall, 125 (66.1%) devices had multiple recalls, with a median of 4 (IQR, 3-11) recalls issued per recalled device. As of September 15, 2022, 50 (26.5%) recalls were terminated, with a median of 24 (IQR, 17.3-30.8) months elapsed between recall initiation and termination. Recalls were terminated more commonly among devices recalled once compared to those recalled multiple times (36.2% vs 19.2%; p=0.02) and for recalls that recommended discontinuing further use of affected devices compared to those that recommended device assessment and/or education of affected population (31.8% vs 18.2%; p=0.04). High-severity medical device recalls are common and affect millions of device units annually in the US. Recall termination takes a significant amount of time, putting patients at risk for serious safety concerns.

Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study

ObjectivesTo examine valsartan, losartan and irbesartan usage and switching patterns in the USA, UK, Canada and Denmark before and after July 2018, when the first Angiotensin-Receptor-Blocker (ARB) (valsartan) was recalled.DesignRetrospective...

Controlling Ethylene Oxide residues in export food production at CJ Foods Vietnam Co., Ltd.

Ethylene oxide (EO) is a gas used in some countries as a fungicide, bactericide, and insecticide in food. The lack of uniformity in EO regulations worldwide resulted in many products being placed on the market and used by consumers at the time the recall notice was issued, causing damage to business and consumers. Therefore, it is very important for enterprises to implement risk-based assessment and management. This report provides control method and analysis results of EO residue testing data in raw materials at CJ Foods Vietnam during the period from August 2021 to the end of July 2022. Since then, recommendations for Vietnamese regulations and businesses in controlling EO have been made.  

Cancer Risk Associated with Continuous Positive Airway Pressure: A National Study.

In 2021 the U.S. FDA issued a Class 1 safety recall notice for specific devices due to a risk of carcinogen exposure. The objective of this study was to evaluate reports of cancer linked to CPAP devices to understand implications for the field of sleep medicine. Cases of cancer involving CPAP devices were retrieved from the MAUDE database from 2014 to 2021 and analyzed with descriptive statistics. A total of 2571 patient injuries were associated with CPAP. Reports of cancer (n=209; 4.62%) were the second most commonly documented patient problem associated with CPAP, although 1950 (43.13%) patients had a device problem without an associated injury. Of the 209 cancer cases associated with CPAP, 200 (95.7%) of the adverse event reports were received by the FDA in 2021. There were 174 (9.15%) descriptions of the CPAP polyurethane sound abatement foam degrading in association with a cancer diagnosis, but degradation was more commonly not associated with malignancy (n=1728; 90.85%). Other frequently documented CPAP device problems included broken devices (n=279; 6.92%), fire (n=182; 4.51%), and patient-device incompatibility (n=144; 3.57%). Malignancy associated with CPAP devices has been reported; however, future studies are required to establish causation. Given 95.7% of those documented cases were reported in 2021, otolaryngologists should be prepared to discuss the risks of carcinogenesis associated with CPAP. The otolaryngology community should also be aware of the potential bandwagon effect and the implications for CPAP compliance. 4 Laryngoscope, 132:2270-2274, 2022.

Duct Tape for the Frequency Domain: If This Ol’ Hack Don’t Fix It, It Ain’t Broke [Shop Talk: What You Didn’t Learn in School

Dominant pole compensation has a problem. It has always had a problem. But don’t panic, this is not a recall notice. And it’s not about amplifiers. An ancient solution to the dominant pole problem is one of the most useful, general-purpose techniques that you can have in your tool kit. To show off its utility, we’ll use it to subdue the ringing in power supply wiring, but you can apply it to patch up all kinds of stability, resonance, and phase problems in the frequency domain.

1258. The Eyes Have It: Investigating a Cluster of Non-lactose Fermenting Gram-Negative Bacilli From Donor Corneal Rim Tissue

BackgroundFollowing corneal transplant, donor corneal rim tissue are sometimes cultured to help predict the risk of post-keratoplasty endophthalmitis. In July 2016, the Infection Control (IC) team was notified by the microbiology laboratory of three donor corneal rim cultures growing non-lactose fermenting (NLF) Gram-negative bacilli, which was unusual for this type of specimen. The IC team initiated an epidemiological outbreak investigation to determine the source of the NLF Gram-negative bacilli.MethodsA 12-month retrospective review of donor corneal rim cultures was performed from July 2015 to July 2016, with continual prospective monitoring of donor corneal rim cultures. The protocols used to prepare corneal donor tissues were reviewed. The standard protocol included flooding the tissue with povidone iodine followed by rinsing with a sterile saline solution and then placement in a sterile container with Opitsol GS (a preservative solution with gentamycin and streptomycin). The sterile saline rinse that was normally used for processing had been on back order and had been replaced with an alternative brand from March 2016 to July 2016. Unopened bottles of the alternative brand of sterile saline fluid and Optisol GS were sent to an outside laboratory for bacterial culture and remaining product was temporarily quarantined.ResultsMicrobiology review revealed seven donor corneal rim cultures positive for NLF Gram-negative bacilli from May to July 2016. Organisms isolated from the donor corneal rim tissue included Achromobacter xylosoxidans (4), Burkholderia cepacia (3), Stenotrophomonas maltophilia (2), and Elizabethkingia meningoseptica (1). Sterility cultures of Opitsol GS demonstrated no growth. Sterility cultures of the sterile saline rinse grew Gram-positive and -negative bacteria from all samples. A FDA MedWatch was submitted in July 2016, and on September 6, 2016 an FDA recall notice was published. The quarantined saline was permanently removed. No clinical infections associated with the positive donor corneal rim cultures were identified.ConclusionMicrobiologists are the front line for IC surveillance. Close partnership between the IC team and the microbiology laboratory can help identify potential outbreaks by alerting them of the growth of atypical organisms or clusters.Disclosures All authors: No reported disclosures.

Vehicle Simulator: Virtual Trip Runner (VTR)/ Real Time Recorder (RTR)

This topic is an attempt to develop an open source vehicle simulator for use by anyone needing realistic vehicle data delivered as it would be in a real vehicle. As you probably know, most vehicles nowadays have an On-Board Diagnostic (OBD) connector which is wired up to the car’s internal computer. It is used in many garages where the mechanic can probe the car through the OBD connector and read out parameters onto a display. In an Internet of Things (IoT ) world where the car can be easily connected to the Internet (perhaps via Bluetooth to a smart phone), it could automatically search an online knowledge base and not only report a fault code but also let you know the most likely cause either based on the car’s personal history or on the environment (an expert system could conclude “it is minus 15 degrees Celsius outside, and there is a water leak, and it is likely to be a cracked hose due to the cold temperature – and there was a manufacturer recall notice concerning this hose”). There will be whole sectors of applications such as, safer driver operation of the vehicle, fewer distractions, more automation, safer mechanical performance, better & more timely maintenance warnings, lower cost operation and lower maintenance costs.

Controversy Surrounding ROCKET-AF: A Call for Transparency, But Should We Be Changing Practice?

Controversy Surrounding ROCKET-AF: A Call for Transparency, But Should We Be Changing Practice?

“De terughaalactie geld alleen voor de hierboven afgebelede pizza’s geldig.”

Consumers’ responses to product recalls with language errors Consumers’ responses to product recalls with language errors Product recall notices not only warn consumers for faulty products, they also limit the damage which may be caused to the company. But what happens when the product recall notice itself contains errors? This study investigated the effects of three different types of language errors: typographical errors, verb errors and sentence errors. Four versions of a product recall were created. The control condition contained no errors. The other three versions contained either five typos, five grammatical conjugation errors or five poorly formed sentences. Participants (N = 710) were randomly assigned to one of the four conditions. Results indicate that participants who detected the errors, had lower attitudes towards the advertisement and the company than participants in the control condition and participants who failed to detect the errors. Poorly formed sentences also had a negative impact on consumers’ brand evaluations and their future product purchase intentions. Hence, language errors in product recall notices can have negative consequences for companies.

Rethinking medical device regulation

Rethinking medical device regulation

Infectious disease surveillance update

Listeria in USA Offi cials from the US Centers for Disease Control and Prevention (CDC) continue to advise people not to eat cantaloupe melons produced by Jensen Farms in Colorado, USA, as the death toll from an outbreak of listeriosis linked to the fruits had risen to 23 by Oct 10. Four outbreak-associated strains of Listeria monocytogenes have been the cause of 109 reported infections in 24 states, with the CDC expecting more cases in coming weeks due to the incubation period before symptoms present. Meanwhile the US Food and Drug Administration (FDA) has issued a recall notice on romaine lettuce produced by True Leaf Farms of Salinas, CA, due to potential L monocytogenes contamination discovered during an FDA research programme.

Task Reality vs. Task Fantasy… How the Concept of Real-World Use Affects Patient Safety

<i>Task Reality vs. Task Fantasy…</i> How the Concept of Real-World Use Affects Patient Safety

Control of an Outbreak of Burkholderia cepacia at a Large Acute Care Hospital

BACKGROUND/OBJECTIVES: In May 2005, an increase in the organism <i>Burkholderia cepacia</i> was noted at a 903-bed urban hospital. A similar increase was later noted at a second 302-bed facility that is part of the same hospital system. Control of this outbreak and identification of its source were the main objectives. <i>B. cepacia</i> is a gram negative organism that is similar to Pseudomonas, and is commonly found in soil and water. Though relatively rare in the hospital setting, it is an important pathogen in immunocompromised patients, especially those with Cystic Fibrosis. Hospital outbreaks have often been linked to common contaminated sources, such as disinfectants, IV solutions, nebulizer solutions, and medical devices. METHODS: All patients found positive for <i>B. cepacia</i> were placed into Contact Precautions with dedicated staff for the duration of admission, as well as any subsequent admissions. Hand hygiene and compliance with isolation practices were reinforced through in-person in services. Surveillance cultures were performed on two separate occasions to identify and isolate previously unidentified cases. A common source for the outbreak was sought by culturing available lots of common fluid-based products. Respiratory Therapy policies and procedures were also reviewed. All available isolates were saved, and compared using Pulse-Field Gel Electrophoresis (PFGE). RESULTS: Between May and October of 2005, 40 patients with <i>B. cepacia</i> were identified. No further cases were identified over the next two-month period. PFGE results confirmed 37 of the 40 patients to have a single, outbreak-related strain. Positive specimens included 9 respiratory, 8 blood, 24 urine, 3 intravascular catheter tips, and 1 bone marrow. No commonalities in terms of specific location, diagnosis, medications, or procedures were identified. Isolates from patients in the smaller facility were also typed using PFGE, and were found to be identical. All surveillance cultures of fluids-based products were negative. However, a recall notice in late August 2005 of a non-alcohol mouthwash contaminated with <i>B. cepacia</i> linked this outbreak to a larger national outbreak. This link was confirmed by showing the outbreak strain was identical to isolates from the contaminated mouthwash as confirmed by the Centers for Disease Control and Prevention using PFGE. Contaminated lots were not identified by either facility at the time of the recall, and additional cases of <i>B. cepacia</i> were felt to be due to cross-transmission between patients. CONCLUSIONS: Although introduction of <i>B. cepacia</i> into the hospital was by a common source, interruption of secondary transmission is needed. In these instances, implementation of comprehensive infection control measures, with multi-disciplinary cooperation, is essential.

Consumers iews on text characteristics of product recall notices

Consumers who have suffered as a result of a product defect can claim compensation from the producer. By placing a product recall notice, producers can reduce their liability. Ideally, such a notice should protect the image of the company as well as warn consumers. The problem is that a clear warning may damage the image of the company that placed the notice. This study reports on experiments carried out among 128 female shoppers to gain insight into how a recall notice should be worded in order to protect the company’s image and, yet to be clear. Split-run tests were carried out to determine whether Minimisation (minimising the danger of the defect) and Bolstering (stressing the company’s good traits) contributed positively to the image of the company and whether inclusion of pictures, a list format, a reader-oriented approach, Minimisation, and Bolstering contrib- uted positively to the clarity of the notice. Likert scales were used to determine which heading drew most attention and through which channels consumers prefered to be informed about a product recall. According to our respondents, a recall notice including Minimisation strategies protects the company’s image more than one without such strategies. A recall notice is consid- ered clearer when it includes a picture, when it contains elements to highlight the structure of the information, and when it does not include Bolstering. According to our respondents, the most attention-grabbing heading is ‘Waarschuwing’ warning), and they prefer to be informed about product recalls through newspapers and television.

The influence of politeness on the perception of product recall notices

When companies decide — or are forced — to publish a product recall notice, their aim is to give consumers clear information on how to handle the problem and to warn them of a possible danger. On the other hand companies try to preserve their corporate image in order to guarantee a (commercial) relation in the future. This article deals with the question whether politeness strategies lead to differences in the appreciation, acceptance and perception of product recall notices. In two experimental studies we evaluated the effect of positive and negative politeness strategies in different conditions. The results show that the use of elaborated negative politeness strategies positively influences the appreciation and acceptance of the message, and has a positive effect on the perception of the corporate image. However in a context where the product recall warns of a severe risk, writers of product recalls should use politeness strategies more cautiously. In this context the use of politeness strategies even seems to have a negative effect on the acceptability of the recall message.

CDC Report on 20 Years of AIDS: More Than One Million Americans Infected

Cancer PracticeVolume 9, Issue 6 p. 267-270 CDC Report on 20 Years of AIDS: More Than One Million Americans Infected First published: 28 June 2008 https://doi.org/10.1111/j.1523-5394.2001.96005.pp.x —Source: Centers for Disease Control and Prevention. http://www.cdc.gov/od/oc/media/pressrel1/r010601.htm. June 1, 2001. —Source: CA: A Cancer Journal for Clinicians. http://www.ca-journal.org. July 20, 2001. —Source: U.S. Food and Drug Administration. FDA Talk Paper. http://www.fda.gov. July 25, 2001. —Source: U.S. Food and Drug Administration. Recall notice. http://www.fda.gov. July 31, 2001 —Source: Journal of the American Medical Association. Herbal Medicines and Perioperative Care. 2001;286:208-216 —Source: American Cancer Society. ACS News Today. http://www.cancer.org, July 6, 2001. —Source: National Cancer Institute. Press release. http://www.nci.nih.gov. July 2001. Department Editors: Peter S. Houts, PhD and Claudette Varricchio, RN, DSN, FAAN. Queries and contributions to The Front Page may be sent to the Department Editors at Cancer Practice, American Cancer Society, 1180 Avenue of the Americas, New York, NY 10036. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Volume9, Issue6November/December 2001Pages 267-270 RelatedInformation

Strategies of containment in recall notices

To understand how strategies of containment operate in recall notices, a writer or reader must first consider two goals that these notices attempt to accomplish. The first of these goals is obvious: a well-constructed recall notice entices a consumer into returning a defective product to the manufacturer, allowing the manufacturer to repair or replace the product. The second goal, while somewhat less obvious, is equally important: the recall notice controls damage to the manufacturer's reputation. Faced with the unpleasant task of recalling a product, the manufacturer can use that recall notice to mitigate its responsibility for the defective product and to demonstrate its concern for the consumer.

Postcards that pack a punch.

Many orthodontic offices are striving to appear unique in the eyes of the public. One way to accomplish this is to send out an interesting and informative newsletter or to use customized recall, birthday, and special notice cards. The following article is being reprinted with the permission of Magazine, June 23,1994. It illustrates how recent versions of the word processing program WordPerfect can be used to facilitate in house production of a newsletter (or Postcards that Pack a Punch) and provides step-by-step instructions that the reader can use to get started. MNA

Perception of risk from automobile safety defects

Descriptions of safety engineering defects of the kind that compel automobile manufacturers to initiate a recall campaign were evaluated by individuals on a set of risk characteristic scales that included overall vehicle riskiness, manufacturer's ability to anticipate the defect, importance for vehicle operation, severity of consequences and likelihood of compliance with a recall notice. A factor analysis of the risk characteristics indicated that judgments could be summarized in terms of two composite scales, one representing the uncontrollability of the damage the safety defect might cause and the other representing the foreseeability of the defect by the manufacturer. Motor vehicle defects were found to be highly diverse in terms of the perceived qualities of their risks. Location of individual defects within the factor space was closely associated with perceived riskiness, perceived likelihood of purchasing another car from the same manufacturer, perceived likelihood of compliance with a recall notice, and actual compliance rates.