Recall Z-0344-2020 ยท LRO General Surgery Tray
Centurion Medical Products Corporation
Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
| Date | Oct 24, 2019 |
| Status | Terminated |
| Reason | Sterile packaging incomplete seals may compromise sterility of the product |
| Root cause | Process control |
| Action | Centurion medical issued notification was emailed to the affected distributor on October 24, 2019, Centurion's parent company, Med line Industries. Centurion mailed a letter to the single affected medical facility on 10/24/19, via certified mail, return receipt. The letter provides reason for recall, heath risk and action to take: be accessed for use. (1) Identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use 2) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your |
| Quantity | 80 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.