Recall Z-1015-2023 ยท OXQ Dressing Change Tray
MEDLINE INDUSTRIES, LP - Northfield
CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
| Date | Jan 25, 2023 (initiated Dec 23, 2022) |
| Status | Open, Classified |
| Reason | The kit contained an expired component. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries issued a DEVICE RECALL notice to its consignees on 12/23/2022 by First Class Mail. The notice explained the problem and requested the following: "REQUIRED ACTION: -Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. -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. Have the customers document and destroy any affected product. You should include you |
| Quantity | 1050 kits |
| Distribution | US Nationwide distribution in the states of NY, IN, FL, NJ, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.