The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate

FDA device recall Z-2676-2014 · posted 2014-09-22 · Terminated

Recall details

Recalling firm

Peters Surgical

Reason for recall

A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.

Action taken

The sole US distributor (MedAlliance Inc.) was notified of the recall via e-mail on July 16, 2014. IMPORTANT AND URGENT - BATCH RECALL PROCEDURE letters dated June 25, 2014 under the Peters Surgical header were sent to all MedAlliance Inc. consignees. The letters included instructions for consignees to contact MedAlliance Inc. by phone (630-933-8661) or by e-mail (agoos@medalliancesolutions.com) for information on what to do with the recalled products. Consignees were also notified that they can contact Peters Surgical directly at qualite@peters-surgical.com for answers to any additional questions. MedAlliance Inc. sent VOLUNTARY PRODUCT RECALL/WITHDRAWAL LETTER[s] dated June 25, 2014 to all consignees. The letters included instructions for consignees to: 1) discontinue use of and segregate recalled product in a secure location for return to MedAlliance Inc., and 2) to complete and return the enclosed RETURNED GOOD AUTHORIZATION (RGA) FORM to MedAlliance Inc. to arrange for the return of the recalled products. Consignees with any questions about the recall can contact Ms. Alaina Goos, Senior Product Manager, by phone at 630-933-8661 x 104 or via e-mail at agoos@medalliancesolutions.com.

Root cause

Process control

Status

Terminated

Product code

GAT

Quantity affected

22,190 units

Distribution

Worldwide Distribution- US: Nationwide (CA, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, TX, VA, WA); and countries: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, CAMBODI

Date initiated

2014-06-25

Date posted

2014-09-22

Date terminated

2017-12-13

Location

Bobigny, France

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