Recall Z-0584-2007 ยท GCJ Laparoscope, General & Plastic Surgery
Conmed Corporation
FRAZIER Surgical Suction Instrument, 3 Fr. with Control Vent and Obturator, REF 0031030. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
| Date | Mar 13, 2007 (initiated Nov 10, 2006) |
| Status | Terminated |
| Reason | Firm was made aware of instances where the sterile barrier of the instruments had been compromised. |
| Root cause | Packaging process control |
| Action | On 11/10/06, ConMed Corp. sent "URGENT: DEVICE RECALL" letters (dated 11/10/06) to the US and foreign consignees by UPS overnight. The letters instructed the consignees to inspect their stocks of the instruments and that they return all devices. The letters also instructed the distributors to contact their customers that received the instruments and conduct sub-recalls. Additionally, when requested, ConMed notified the distributor's customers (conducted sub-recalls) by UPS overnight mail. This recall action is to the end user level. Accompanying each letter was an effectiveness check form to |
| Quantity | 32,008 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.