Reported Oct 1, 2014 · Terminated
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene…
Peters Surgical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Peters Surgical · 42 Rue Benoit Frachon · Bobigny, N/A · N/A
Is this the product you have?
- 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-
- UnitSutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. -
- Box36 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)
- Lot codes and dates
63 of 63 products
Products covered by this recall # Barcodes Product as published 1 3661522034989Item reference: 19P20Q , Batch number: 1135 , Expiration date: 10/2018 , GTIN on box label: 3661522034989 2 3661522034446Item reference: 19P30AC , Batch number: 942720 , Expiration date: 03/2018 , GTIN on box label: 3661522034446 3 3661522034477Item reference: 19P30AE , Batch number: 7627 , Expiration date: 04/2019 , GTIN on box label: 3661522034477 4 3661522034477Item reference: 19P30AE , Batch number: 942910 , Expiration date: 02/2018 , GTIN on box label: 3661522034477 5 3661522034477Item reference: 19P30AE , Batch number: 971670 , Expiration date: 05/2018 , GTIN on box label: 3661522034477 6 3661522034552Item reference: 19P30AK , Batch number: 942530 , Expiration date: 03/2018 , GTIN on box label: 3661522034552 7 3661522034552Item reference: 19P30AK , Batch number: 978580 , Expiration date: 06/2018 , GTIN on box label: 3661522034552 8 3661522034576Item reference: 19P30AN , Batch number: 942500 , Expiration date: 02/2018 , GTIN on box label: 3661522034576 9 3661522034606Item reference: 19P30AQ , Batch number: 2480 , Expiration date: 10/2018 , GTIN on box label: 3661522034606 10 3661522034606Item reference: 19P30AQ , Batch number: 5508 , Expiration date: 02/2019 , GTIN on box label: 3661522034606 11 3661522034606Item reference: 19P30AQ , Batch number: 994990 , Expiration date: 07/2018 , GTIN on box label: 3661522034606 12 3661522034606Item reference: 19P30AQ , Batch number: 1008710 , Expiration date: 08/2018 , GTIN on box label: 3661522034606 13 3661522034262Item reference: 19P30N , Batch number: 942420 , Expiration date: 02/2018 , GTIN on box label: 3661522034262 14 3661522034279Item reference: 19P30R , Batch number: 4370 , Expiration date: 01/2019 , GTIN on box label: 3661522034279 15 3661522034279Item reference: 19P30R , Batch number: 5021 , Expiration date: 01/2019 , GTIN on box label: 3661522034279 16 3661522034279Item reference: 19P30R , Batch number: 5557 , Expiration date: 02/2019 , GTIN on box label: 3661522034279 17 3661522034279Item reference: 19P30R , Batch number: 948700 , Expiration date: 03/2018 , GTIN on box label: 3661522034279 18 3661522034279Item reference: 19P30R , Batch number: 978410 , Expiration date: 06/2018 , GTIN on box label: 3661522034279 19 3661522034323Item reference: 19P30S , Batch number: 994580 , Expiration date: 07/2018 , GTIN on box label: 3661522034323 20 3661522034347Item reference: 19P30T , Batch number: 4371 , Expiration date: 01/2019 , GTIN on box label: 3661522034347 - Amount recalled
- 22,190 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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