Recall Z-2040-2020 ยท LRO General Surgery Tray
Medline Industries Inc
Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ5
| Date | Mar 9, 2020 |
| Status | Terminated |
| Reason | Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch. |
| Root cause | Process control |
| Action | The firm initiated the recall by letter on 03/09/2020. The letter explained the problem and requested the consignee take the following actions: "1. Immediately check your stock for the specific kit number and the affected kit lot number in the attached list. Quarantine any kits with the listed lot numbers. If you dont have any of the lots listed above skip to step 3. 2. Affix the enclosed stickers on the affected kits and return to stock. If additional stickers are needed please call 866-359-1704. Please be sure NOT to use the Sterile Pre-Saturated Povidone Iodine Sponge Products compon |
| Quantity | 92,902 kits |
| Distribution | nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.