POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501. ASSEMBLED

FDA device recall Z-0593-2007 · posted 2007-03-13 · Terminated

Recall details

Recalling firm

Conmed Corporation

Reason for recall

Firm was made aware of instances where the sterile barrier of the instruments had been compromised.

Action taken

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 be completed by the consignee, and faxed back to ConMed Corp. The instruments are to be returned to ConMed Corp. in Utica, NY. For questions, the consignee can contact Ms. Nancy Crisino by phone at (315) 624-3078 or by fax at (315) 624-3089.

Root cause

Packaging process control

Status

Terminated

Product code

GCJ

Quantity affected

2,232,896 units

Distribution

Worldwide

Date initiated

2006-11-10

Date posted

2007-03-13

Date terminated

2012-07-31

Location

Utica, NY