RecallRadar

FDA Device recall Z-1708-2014

Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture

On 2014-06-11 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 one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (ten….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1708-2014
ClassificationClass II
Statusterminated
Initiated2014-04-23
Published2014-06-11
Last updated2026-09-13 11:53 UTC
CompanyC P Medical
DistributionUS

Product

Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. 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 (2.0 metric), PS-1 Needle

Reason

CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength.

Identifiers

code_infoLot 130826-08, expiration 2015-07.

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-1708-2014%22

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