Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (

FDA device recall Z-0809-2007 · posted 2007-05-24 · Terminated

Recall details

Recalling firm

C P Medical

Reason for recall

Potential for sterility of product to be compromised. Suture package seals incomplete or missing.

Action taken

On 04/03/2007 the firm notified its Polyester product (Polybond) customer by telephone and followed up on 04/09/2007 with a letter via certified mail requesting the distributor to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/09/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical. On 04/20/2007 the firm notified its Polypropylene and Polydioxanone product customers by letter dated 04/17/2007 via certified mail requesting distributors to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/18/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical.

Root cause

Other

Status

Terminated

Product code

GAM

Quantity affected

13,596 suture packets

Distribution

Firm distributes products to human and veterinary medical device distribution centers worldwide. Polybond Polyester sutures, product CP523A, were distributed to one distribution center in South Africa

Date initiated

2007-04-03

Date posted

2007-05-24

Date terminated

2008-08-01

Location

Portland, OR

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