—#212784

Product

Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K213481
Affected lot / code info: Item No. DYNJ35520B, DYNJ38529F, DYNJ43406F, DYNJ43421D, DYNJ69185A, DYNJ69340B, DYNJ88923; UDI (case): 40198459106904, 40195327693870, 40198459074005, 40198459074784, 40195327582839, 40198459026127, 40198459216856; UDI (each): 10198459106903, 10195327693879, 10198459074004, 10198459074783, 10195327582838, 10198459026126, 10198459216855; Lot No. (Shelf Life) 24KMB843(05/31/2027), 24IMD400(01/31/2027), 24IMB784(01/31/2027), 24LBK460(02/28/2027), 24JBY288(12/31/2026), 24LBJ155(01/31/2027), 24JBU154(12/31/2026), 24HBP361(11/30/2026), 24HBA919(10/31/2026), 24JBX700(06/30/2026), 24JBC370(04/30/2026), 24IBI711(04/30/2026), 24HBO453(04/30/2026), 24HBA954(01/31/2026), 24JBK365(04/30/2026), 24HBR810(04/30/2026), 24GBX503(03/31/2026), 24LBO297(06/30/2026), 24JBV432(06/30/2026), 24IBU974(05/31/2026), 24HBR072(04/30/2026), 25ABB569(02/10/2026).

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

Medline distributed an IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification, dated 2/13/25, to consignees who purchased individually packaged Proxima sterile surgical drapes and kits that contained Proxima sterile surgical drapes. Consignees that purchased kits containing recalled product are to immediately check stock for affected kits and place them in quarantine. Consignees are to complete the provided response form to receive over-labels to be applied to quarantined kits with additional instructions to remove the affected components prior to use of the kit. Consignees that purchased individual units of Proxima sterile surgical drapes are to immediately check stock for affected devices and immediately destroy identified product. Consignees are to complete the provided response form to obtain credit for the destroyed product. If a consignee is a distributor or have further distributed affected devices, they are instructed to forward the provided recall notification. Questions about this recall can be directed to Medline via phone at 866-359-1704 or by email to recalls@medline.com.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2025-02-13
Posted by FDA: 2025-03-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212784. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.