Recall Z-2676-2014 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Peters Surgical
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with
| Date | Sep 22, 2014 (initiated Jun 25, 2014) |
| Status | Terminated |
| Reason | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. |
| Root cause | Process control |
| Action | 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 quest |
| Quantity | 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, CAMBODIA, CHINA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, HUNGARY, INDO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060163 | CARDIOFLON, CARDIOXYL Peters Surgical, Oct 11, 2006 |