MEDLINE INDUSTRIES, LP - Northfield: Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.

Hazard

Potential breach in pouch packaging which could lead to loss of sterility.

Details from the source

Reason for recall: Potential breach in pouch packaging which could lead to loss of sterility. Distribution: US Nationwide distribution. Quantity: 506 units Lot/code info: Item No. DYNJ34603F & DYNJ903916I; UDI (case): 40198459143596 & 40195327580118; UDI (each): 10198459143595 & 10195327580117; Lot No. (Shelf Life) 25AMD464(11/30/2029), 24JMC011(04/30/2029), 25ABA362(09/30/2025), 24KBT718(02/28/2026), 24JBE997(09/30/2025), 24IBM203(02/28/2026).

UPC codes

40198459143596, 40195327580118, 10198459143595, 10195327580117

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.