6 medical device recalls to know

The FDA has flagged six medical device recalls and corrections confirmed over the past two weeks, affecting convenience kits, ventilators, sodium chloride flushes, nitric oxide delivery systems, esophageal monitoring capsules and epidural kits.

Here are six recalls to know:

1. Convenience kits (AVID Medical): On Sept. 21, the FDA confirmed a correction for kits containing sodium chloride ampules manufactured by Huons and recalled by Spectra Medical Devices after finding the ampules could expose patients to microorganisms, endotoxins or foreign matter. As of Aug. 10, AVID Medical had reported no serious injuries or deaths.

2. Ventilators (CooperSurgical): On Sept. 21, the FDA confirmed a recall of INCA Infant and Neonatal Nasal CPAP sets after finding certain lots may have a loose connection between the tubing and nasal cannula, which can cause a loss of CPAP pressure and decreased oxygenation. As of Aug. 11, the company had reported no serious injuries or deaths.

3. Sodium chloride flushes (Spectra Medical Devices): On Sept. 18, the FDA classified Spectra’s removal of Huons-manufactured sodium chloride flush ampules as its most serious recall type after a Huons manufacturing inspection raised sterility concerns. The products are used to flush IV tubing and devices such as central lines and implanted ports. As of July 6, Spectra had reported no serious injuries or deaths.

4. Nitric oxide delivery systems (NOxBOX): On Sept. 18, the FDA confirmed a correction updating use instructions for NOxBOXi devices after the company received complaints of oxygen leaks tied to tubing failures, which can lead to interrupted therapy or increased nitric oxide dosing.

5. Esophageal pH monitoring capsule delivery devices (Medtronic and Given Imaging): On Sept. 15, the FDA classified Medtronic’s removal of Bravo CF capsule delivery devices as its most serious recall type. The devices can fail to attach to the esophagus or detach as intended, risking aspiration, perforation or hemorrhage. As of Aug. 10, Medtronic had reported 184 serious injuries and no deaths. It is the second recall tied to the device this year.

6. Epidural kits (Medical Action Industries): On Sept. 10, the FDA confirmed a correction for epidural kits containing Huons-manufactured sodium chloride ampules, warning that use near the spine could lead to abscess formation or spinal root compression. As of July 23, the company had reported no serious injuries or deaths.