Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/

FDA device recall Z-1363-2025 · posted 2025-03-14 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

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

Action taken

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.

Root cause

Packaging process control

Status

Open, Classified

Product code

PUI

Quantity affected

1,482 units

Distribution

US Nationwide distribution.

Date initiated

2025-02-13

Date posted

2025-03-14

Location

Northfield, IL