Recall Z-1180-2024 ยท LRJ Disinfectant, Medical Devices
MEDLINE INDUSTRIES, LP - Northfield
These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES: a) MSC351400AN/Z (7 X 8 , 150 ct canister), b) MSC351410AN/Z (6 x 5 , 150ct canister), c) MSC3560012 (private-labeled 6 x 5 , 150ct canister), d) MSC351450AN (12" x 12", 110ct b
| Date | Feb 22, 2024 (initiated Dec 20, 2023) |
| Status | Open, Classified |
| Reason | There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life. |
| Root cause | Process control |
| Action | Medline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to it consignees on 12/20/2023 via USPS first class mail. The notice explained the problem with the device and requested that the consignee destroy all affected product. Any parties to whom the product was transferred must be notified of the recall communication. For questions, please contact 866-359-1704. |
| Quantity | 1,314,719 units |
| Distribution | US and territories, S. Korea, Panama, and Dubai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.