Recall Z-1530-2025 ยท NAC Dressing, Wound, Hydrophilic
MEDLINE INDUSTRIES, LP - Northfield
Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT 5) Model Number: RA0353818V1, BANDAGE,BLISTER, RITEAID,6EA/BX, 24BX/CS
| Date | Apr 4, 2025 (initiated Feb 19, 2025) |
| Status | Open, Classified |
| Reason | There is a potential for the sterility of the device to be compromised. |
| Root cause | Under Investigation by firm |
| Action | An "URGENT MEDICAL DEVICE RECALL" notification letter dated 2/19/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based u |
| Quantity | 364842 units |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.