C P Medical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0140-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 22, 2014

Date Posted: November 5, 2014

Recall Number: Z-0140-2015

Event ID: 69373

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.

Status: Terminated

Product Quantity: 74 boxes /12 sutures per box; plus an additional 13 sutures

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.

Distribution Pattern:

US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA

Voluntary or Mandated:

Voluntary: Firm initiated