Recall Z-2676-2014— Peters Surgical

Name: FDA recall Z-2676-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-25

Class II · Terminated

Class II FDA medical device recall by Peters Surgical, initiated 2014-06-25, terminated 2017-12-13. It names one FDA 510(k) clearance: K060163. Product: 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 the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).. Reason: A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified..

Recalling firm: Peters Surgical
Classification: Class II
Status: Terminated
Initiated: 2014-06-25
Terminated: 2017-12-13
Firm location: Bobigny, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K060163 — CARDIOFLON, CARDIOXYLPeters Surgical·cleared 2006-10-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.