Recall Z-0941-2025 ยท LRW Scissors, General, Surgical
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO STERILE OPERATING SCISSOR 5.5" B/B C50,Model Number 94-1346; 5) ECONO STERILE MAYO SCISS STR 5.5" CS/50,Model Number 94-1925;
| Date | Jan 16, 2025 (initiated Dec 3, 2024) |
| Status | Open, Classified |
| Reason | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| Root cause | Under Investigation by firm |
| Action | On December 3, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action required: 1. Check your inventory for any affected product lots (see Attachment A). If you have affected product in inventory, discontinue use immediately. 2. Notify Additional Users. If you have further distributed any of the items referenced in this notification, you must notify those downstream customers of this recall. Forward a copy of this letter, along with copies of Attachment A and the Recall Acknowledgement form, for such customers to complete and return to Sklar. 3. Notify Sklar. Please complete |
| Quantity | 252865 units |
| Distribution | Domestic: Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.