Recall Z-0140-2015— C P Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by C P Medical, Inc., initiated 2014-09-22, terminated 2015-02-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- C P Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-22
- Terminated
- 2015-02-17
- Firm location
- Portland, OR, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.