Recall Z-0564-2008

Reason for recall

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.

FDA-determined cause: Packaging process control

Action taken

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 Quality Assurance at 1-800-552-0138 ext. 5225 between the hours of 7 am - 6 pm (MST). International customers were notified on 9/18/07. A second recall letter (dated 10/09/07) was sent to non-respondents of the initial mailing. ConMed plans to send a third recall letter to the non-responders during the week of 12/10/07 which addresses sub-recall notifications to the distributors' customers.