The FDA has flagged eight medical device recalls, corrections and early alerts affecting convenience kits, vascular access devices, IV administration sets, ventilator circuits and catheter introducer kits.
Here are the five recalls to know:
- Convenience kits (Medline): On Aug. 20, the FDA confirmed a correction for kits containing B. Braun components with Huons bupivacaine hydrochloride in dextrose injection, tied to Huons’ recall of the injectable. Compromised injectables carry risks including infection, inflammatory response or reduced anesthetic effectiveness.
- Intraosseous needle sets (Becton Dickinson): On Aug. 17, the FDA confirmed the removal of certain Intraosseous Vascular Access System Needle Sets after users reported difficulty removing the obturator, or stylet, following placement. As of July 22, BD had reported 45 serious injuries and four deaths.
- Intravascular administration sets (Baxter): On Aug. 13, the FDA confirmed the removal of Duo-Vent solution sets after finding a risk of air bubbles forming in the drip chamber and tubing when pressure is applied, which could deliver air into the infusion line during pressure infusions.
- Breathing circuit sets (Hamilton Medical): On Aug. 11, the FDA confirmed the removal of a breathing circuit set after identifying a risk that the valve membrane could adhere to the sealing ring, potentially impeding expiratory gas flow.
- Catheter introducers (Abiomed and Oscor): On Aug. 10, the FDA confirmed a correction for introducer kits used with Impella heart pumps following an earlier alert on potential sheath leakage. Hospitals may continue using existing inventory, with a device exchange recommended if leakage is observed.
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