Recall Z-1530-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated February 19, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: 1) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10315040001; 2) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317020005; 3) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317030004; 4) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317120001; 5) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318050003; 6) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318070002; 7) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318080003; 8) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319010004; 9) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319050004; 10) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319060001; 11) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319110002; 12) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319110004; 13) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320030005; 14) CUR5103, UDI-DI:…
Reason for recall
There is a potential for the sterility of the device to be compromised.
FDA-determined cause: Under Investigation by firm
Action taken
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 upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-026 Recall Code: Recall Code 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers document and destroy any affected product, and include your customer s quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-1530-2025
- Initiated
- February 19, 2025
- Posted by FDA
- April 4, 2025
- Product code
- NAC – Dressing, Wound, Hydrophilic
- Quantity
- 364842 units
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1531-2025 Class II | Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number:…There is a potential for the sterility of the device to be compromised. | 02/19/2025Open, Classified |