Recall Z-2221-2024 ยท GCJ Laparoscope, General & Plastic Surgery
ASPEN SURGICAL
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
| Date | Jun 27, 2024 (initiated Jun 3, 2024) |
| Status | Completed |
| Reason | The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised. |
| Root cause | Process control |
| Action | An URGENT: FIELD SAFETY NOTICE (Removal) dated 6/3/24 was sent to customers. Required Actions: Note: Any further distribution or use of the impacted product should cease immediately. 1. Check all storage and usage locations to confirm if you have any lots of the affected item code in your possession. 2. Distributors Please check your inventory for affected products as indicated above. For products that you have distributed, please forward this notification to your customers who have received affected product. Please also provide to Aspen a list of customers who have received these products, |
| Quantity | 1900 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913500 | CHERRY SPONGE O.R. Concepts, Inc., Sep 25, 1991 |