FDA announces Class 1 recalls of ventilator, eye injection kits

Editor's Note

The US Food & Drug Administration has designated recalls of Baxter’s Life2000 Ventilator and the I-Pack Injection Kit from Bausch + Lomb and subsidiary Synergetics Inc. as Class 1, the most severe category indicating serious risk of injury or death.

According to FDA’s July 15 announcement, the ventilator recall was prompted by risk of failure of the battery charging dongle, which can result in desaturation episodes if the system stops running or runs only intermittently. There have been no reported deaths and one reported injury. Users are advised to carefully inspect the dongle and check for alarms before use, secure backup ventilation, review instructional materials, and arrange for the return of impacted products.

Bausch + Lomb and Synergetics recalled certain lots of I-Pack Injection Kits—used to deliver medication to the eye—after being unable to verify that the products had been fully sterilized, FDA reported July 15. Lack of sterilization creates risks including endophthalmitis, vision loss or total loss of the eye, and death. Unique Device Identifiers (UDI)/Lot Numbers to avoid include:

• Bausch + Lomb I-Pack Injection Kit, UDI/DI 20841305107544; Lot Number P62764979R.
• Bausch +Lomb I-Pack Injection Kit with drape, UDI/DI 20841305107551, Lot Number P63044983R.
• Bausch +Lomb I Pack Injection Kit, UDI/DI 20841305107605, Lot Number P62764965R.
• Bausch+Lomb I-Pack Injection Kit UDI/DI 20841305107612, Lot Number P627664970R.