FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator, 10 French, Product Code: 003110

FDA device recall Z-0558-2008 · posted 2008-02-02 · Terminated

Recall details

Recalling firm

Conmed Corporation

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.

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.

Root cause

Packaging process control

Status

Terminated

Product code

GCJ

Quantity affected

19,334 instruments

Distribution

Nationwide and Worldwide Distribution

Date initiated

2007-09-12

Date posted

2008-02-02

Date terminated

2012-08-30

Location

Utica, NY