Monoswift PGCL [poly — Class II medical device recall Z-0140-2015
Terminated recall by C P Medical, Inc., reported 2014-11-05, distributed in AR, AZ, CA, FL, ME, MI, NE, OR…. CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical
| Recall number | Z-0140-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C P Medical, Inc., Portland, OR, United States |
| Recall initiated | 2014-09-22 |
| Classified | 2014-10-27 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-02-17 |
| Distributed | AR, AZ, CA, FL, ME, MI, NE, OR, SC, WA |
| Reason classes | potency |
| Lot numbers | 130513-16, 130618-12, 130729-17, 140117-03, 140127-02, 140128-06, 140304-14, L345, L346, L463, L923, L942 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0140-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.