Recall Z-3013-2020 ยท OXQ Dressing Change Tray
Medline Industries Inc
Central Line Dressing Change Tray
| Date | Aug 12, 2020 |
| Status | Terminated |
| Reason | Potential of incomplete seals impacting the sterility of the kit. |
| Root cause | Under Investigation by firm |
| Action | On August 26th 2020 the firm sent an Urgent Recall letter to its consignees with the following information: This letter is to inform you that Medline Industries, Inc. is recalling our Central Line Dressing Change Tray DYNDC1928C and lot number 2020021990 due to the potential of incomplete seals impacting the sterility of the kit. REQUIRED ACTION: 1. Immediately check your stock for item number DYNDC1928C and the affected lot number, 2020021990. 2. Please destroy affected product, and complete the enclosed destruction form listing the quantity destroyed. Even if you do not have any affected |
| Quantity | 60 kits |
| Distribution | Domestic Distribution: MN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.