Home / Recalls / C P Medical, Inc. / Z-0140-2015

Z-0140-2015 Class II Terminated

Recalled by C P Medical, Inc. — Portland, OR

Recall Details

Product Type: Devices
Report Date: November 5, 2014
Initiation Date: September 22, 2014
Termination Date: February 17, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 74 boxes /12 sutures per box; plus an additional 13 sutures

Product Description

Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. 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.

Reason for Recall

CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.

Distribution Pattern

US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA

Code Information

Product Lot Number (s) Code L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06.