MEDLINE INDUSTRIES, LP - Northfield: Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. 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: 1,118 units Lot/code info: Item No. CDS985210G, CDS985210G, CDS985210G, DYNJ65826A, DYNJ65826A, DYNJ65826A, DYNJ65826A, DYNJ87398, DYNJ87398, DYNJ908743C, DYNJ908743C, DYNJ908743C, DYNJ908743C, DYNJ908744C, DYNJ908744C, DYNJ908744C, DYNJ910326B; UDI (case): 40195327553310, 40195327516193, 40198459034405, 40195327636297, 40195327636280, 40198459075002; UDI (each): 10195327553319, 10195327516192, 10198459034404, 10195327636296, 10195327636289, 10198459075001; Lot No. (Shelf Life) 24LBK011(04/30/2026), 24JBR548(02/28/2026), 24IBN166(02/28/2026), 24KMF425(06/30/2026), 24JMI243(06/30/2026), 24IMI316(05/31/2026), 24HMH127(04/30/2026), 24JBW476(02/28/2026), 24HBK163(02/28/2026), 24KBA490(02/28/2026), 24JBM980(02/28/2026), 24JBB973(02/28/2026), 24IBQ750(03/31/2026), 24JBM981(02/28/2026), 24JBH713(02/28/2026), 24HBJ792(02/28/2026), 24KBQ357(12/31/2025).

UPC codes

40195327553310, 40195327516193, 40198459034405, 40195327636297, 40195327636280, 40198459075002, 10195327553319, 10195327516192, 10198459034404, 10195327636296, 10195327636289, 10198459075001

Source

Official record: FDA (Device enforcement) ↗

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