Home / Recalls / C P Medical Inc. / Z-1708-2014

Z-1708-2014 Class II Terminated

Recalled by C P Medical Inc. — Portland, OR

Recall Details

Product Type: Devices
Report Date: June 11, 2014
Initiation Date: April 23, 2014
Termination Date: September 12, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: US distribution:4 boxes/ 12 sutures per box (48 total); Outside US: 44 boxes/12 sutures per box. (528 total).

Product Description

Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek¿ pouch. It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric), PS-1 Needle

Reason for Recall

CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength.

Distribution Pattern

Worldwide Distribution - US Nationwide

Code Information

Lot 130826-08, expiration 2015-07.