Z-0140-2015 Class II Terminated
FDA device recall Z-0140-2015 was initiated by C P Medical, Inc. on September 22, 2014 and is designated Class II. 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 ov… The recall status is terminated (terminated February 17, 2015). Affected quantity: 74 boxes /12 sutures per box; plus an additional 13 sutures.
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.