The FDA has flagged six medical device recalls and early alerts over the past two weeks, covering hemodialysis bloodlines, a heparin-induced thrombocytopenia test, hospital beds, convenience kits, hospital glucose meters and a portable ultrasound. Here are the six to know:
- Hemodialysis bloodline sets (B. Braun Medical): On Nov. 2, the FDA issued an early alert after B. Braun asked customers to remove three lots of its Streamline Bloodline Set for Dialog+. The company said the required solvent application step during assembly was not performed, resulting in inadequate bonding of the dialyzer connector. The connector may detach or leak during priming or treatment, which could cause blood loss, clotting or air entering the circuit. B. Braun told customers Oct. 20 to quarantine and return affected products. As of Oct. 10, B. Braun Medical had reported no serious injuries or deaths associated with the issue.
- HIT antibody test (Instrumentation Laboratories/Werfen): On Oct. 30, the FDA classified Werfen’s removal of four lots of HemosIL AcuStar HIT-IgG(PF4-H) as its most serious recall type. Werfen’s investigation confirmed performance variability, with a negative bias of 20% to 35%, in the affected lots that may not be reliably detected through routine calibration and quality control testing. That could produce false negatives and delay recognition of heparin-induced thrombocytopenia. Werfen advised labs to destroy the affected lots and find an alternative testing method because a supply interruption is expected. As of Sept. 3, it had reported no serious injuries or deaths.
- Hospital beds and accessories (Medline): On Oct. 29, the FDA issued an early alert after Medline announced the discontinuation and market exit of all Medline Brand beds, pendants, accessories and replacement parts. The beds’ electrical components may overheat and catch fire, and accessories, pendants or loose rails can create entrapment or asphyxiation risks. Medline updated its guidance Oct. 24 to allow beds to stay in use until they are repaired or replaced, as long as users unplug them when not repositioning a patient and avoid extension cords. As of Oct. 20, Medline had reported two deaths and 16 serious injuries associated with the issues.
- Convenience kits (Cardinal Health): On Oct. 20, the FDA issued two early alerts tied to Cardinal Health Presource kits containing BD Alaris pump infusion sets affected by BD’s October recall. In one action, Cardinal Health told customers to quarantine the kits and label them so clinicians remove and discard the recalled sets. In the other, it directed customers to BD’s updated performance data and to use an alternative pump when the sets’ performance is not clinically appropriate. As of Aug. 19, BD had not reported any serious injuries or deaths.
- Hospital glucose meters (Nova Biomedical): On Oct. 20, the FDA classified Nova Biomedical’s correction for its StatStrip Glucose Hospital Meter Gen 2.0 as its most serious recall type, then updated its recommendations Oct. 30. When staff scan a patient ID or quality control barcode, prior information may stay on the screen, and if accepted, the glucose result can be assigned to the wrong patient. Nova advises facilities with an alternative meter to stop using affected units until a software update, which it plans to roll out in phases in November. It has also implemented a shipment hold on all new model StatStrip Glucose Hospital Meter Systems (Gen 2.0). As of Oct. 5, Nova had reported one serious injury and no deaths.
- Diagnostic ultrasound system (Philips Ultrasound): On Oct. 19, the FDA classified Philips’ updated use instructions for all Lumify systems as its most serious recall type, following its Oct. 9 early alert. Beyond the previously disclosed software registration issue, Philips also reported that the connection between the Lumify transducer USB cable and a customer’s tablet or phone may disconnect or become unstable during use. As of Sept. 29, Philips had reported four deaths and eight serious injuries.
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