Recall Z-0559-2008 ยท GCJ Laparoscope, General & Plastic Surgery
Conmed Corporation
FRAZIER Surgical Suction Instrument, 8 French with Control Vent and Obturator, Product Code: 0033080, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501
| Date | Feb 2, 2008 (initiated Sep 12, 2007) |
| Status | Terminated |
| Reason | Sterility (package integrity) compromised -- Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present. |
| Root cause | Packaging process control |
| Action | URGENT-Device Recall Letters (dated 9/10/07) and FIELD CORRECTIVE ACTION CERTIFICATION forms were sent via Certified Mail to affected customers the week of 9/09/07 (mailed on 9/12/07). The recall letters informed the consignees of the recall due to potentially inadequate seals of the instruments, and instructed them to review their inventory of the instruments checking them for inadequate seals. The letters also instructed the consignees to complete the form and fax it back by 9/21/07. For those consignees that have any of the recalled instruments or may have questions, please contact ConMed |
| Quantity | 271,768 instruments |
| Distribution | Nationwide and Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.