Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Recall
- Recall Number
- Z-1365-2025
- Event Number
- 96401
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- FEI Number
- 1417592
- Product Code
- OGR
- Status
- Open, Classified
- Root Cause
- Packaging process control
- Initiated
- February 13, 2025
- Posted
- March 14, 2025
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Potential breach in pouch packaging which could lead to loss of sterility.
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 [email protected].
US Nationwide distribution.
114 units