FDA Device recall Z-0140-2015
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture
- FDA Device
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture by C P Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0140-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-22 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | C P Medical |
| Distribution | AR, AZ, CA, FL, ME, MI, NE, OR, SC, WA |
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.
Identifiers
| code_info | Product Lot Number (s) Code L345; 130618-12. L346; 140304-14. L463;…Product Lot Number (s) Code L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0140-2015%22
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