Recalls and warnings
A class I recall of the Arrow AutoCAT2 and AC3 Optimus Intra-Aortic Balloon Pump Series by Arrow International due to possible breakdown of motor connector wires. The recall includes 2,123 devices distributed from March 15, 2018, to May 1, 2020.
A class I recall of the GlideScope Core One TouchSmart Cable by Verathon Inc. due to partial or complete loss of image during use. The cable is used to connect the GlideScope Spectrum single-use video laryngoscope and GlideScope Video Baton 2.0 to video monitors. There have been 74 complaints and nine medical device reports, but no reported injuries or deaths, related to this issue.
A warning that there has been a sharp increase in hand sanitizer products that have tested positive for methanol contamination. Methanol, or wood alcohol, can be toxic when absorbed through the skin and can be life-threatening when ingested. It is not an acceptable ingredient for hand sanitizers. The FDA is aware of adults and children ingesting hand sanitizer products contaminated with methanol, which has led to recent adverse events including blindness, hospitalizations, and death. In response to this issue, several types of hand sanitizer products have been recalled.
A recall of 12 lots of metformin hydrochloride extended-release tablets USP (750 mg in 100-and 500-count bottles) by Granules Pharmaceuticals Inc. due to the detection of excess levels of N-nitrosodimethylamine (NDMA) in one lot. In addition, Lupin Pharmaceuticals Inc. recalled all batches of metformin hydrochloride extended-release tablets USP (500 mg and 1,000 mg) due to detection of NDMA. All recalled products were distributed nationwide.
A recall of one lot of daptomycin for injection (500 mg/vial) by Mylan Institutional LLC due to the presence of particulate matter in one vial. The affected batch was distributed nationwide between April and May 2020.
A recall of two lots of dexmedetomidine hydrochloride in 0.9% sodium chloride injection (200 µg/50 mL [4 µg/mL], 50-mL fill in 50-mL vials) by Fresenius Kabi USA due to potential cross-contamination of lidocaine. The affected lots were distributed nationwide between June 3, 2019, and April 8, 2020.
A reissued emergency use authorization for the LabCorp COVID-19 RT-PCR Test, including two new indications for the test in people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, as well as to allow pooled sample testing. The FDA reissued the authorization after the company provided scientific data demonstrating the test's ability to detect SARS-CoV-2 in a general, asymptomatic population. In addition, the reissuance includes authorization for LabCorp to test pooled samples containing up to five individual swab specimens collected under observation.
A reissued emergency use authorization for the Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR test. The test is now authorized for use with pooled samples containing up to four individual upper-respiratory swab specimens collected under observation.
Emergency use authorizations for two serology-based tests for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2. The BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test by Xiamen Biotime Biotechnology Co. Ltd. and the CareStart COVID-19 IgM/IgG by Access Bio Inc. are intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
A temporary policy for compounding of dexamethasone sodium phosphate by outsourcing facilities and pharmacy compounders. The industry guidance is intended to address shortages of certain drugs urgently needed for patients hospitalized with COVID-19.
An emergency use authorization for the GammaCore Sapphire Non-invasive Vagus Nerve Stimulator. The device is intended for use at home or in health care settings to treat adults with known or suspected COVID-19 who are experiencing worsened asthma-related shortness of breath and reduced airflow and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by the patient's clinician. It is placed on either side of the patient's neck for two consecutive two-minute stimulations at the onset of respiratory distress or shortness of breath, for up to 24 stimulations every 24 hours.
An emergency use authorization for the SleepWeaver Prevent CPAP Mask. The product is a continuous positive airway pressure (CPAP) mask that was modified for use during the pandemic by combining it with an N95 respirator.
A letter to clinical laboratory staff and clinicians alerting them of increased risk of a false-positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found about 3% of results to be false positive. The FDA is working with Becton, Dickinson and Company (BD) to resolve the issue.