Recall Z-2233-2021 ยท OJH Orthopedic Tray
Medline Industries Inc
Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
| Date | Jul 1, 2021 |
| Status | Terminated |
| Reason | The kits may contain an expired component. |
| Root cause | Employee error |
| Action | Consignees were notified by letter dated and issued on 7/1/2021 via first class mail. The letter informed the consignee the convenience kits were being recalled due to the irrigation bag expiring August 21,2020. The consignee was to immediately check their stock for the affected kit and kit lot number and affix the enclosed sticker on the kit which instructs the consignee to remove the expired irrigation bag and replace it with sterile product from their supply. The remainder of the components may be used. |
| Quantity | 286 total kits for all products |
| Distribution | US Nationwide distribution in the states of MN, NE, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.