Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. T

FDA device recall Z-0140-2015 · posted 2014-10-27 · Terminated

Recall details

Recalling firm

C P Medical, Inc.

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.

Action taken

CP Medical Inc.notified their customers between September 23 through October 3, 2014, of the recall via telephone or e-mail and followed up with a certified letter. Customers were advised to discontinue sale and/or use of the recalled product and return all existing stock to CP Medical. CP Medical also requested their customers to notify their downstream customers of the recall and request they return any unused recalled product, as well as provide information to them regarding distribution of the product. Customers are being asked to fill out and return a questionnaire regarding the recalled product and contact CP Medical Customer Service Representative at 1-800-950-2763 for return authorization and shipping account number. All shipping costs including those from downstream customers will be paid for by CP Medical. Replacement product or credit will be provided.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NEW

Quantity affected

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

Distribution

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

Date initiated

2014-09-22

Date posted

2014-10-27

Date terminated

2015-02-17

Location

Portland, OR