Reported Oct 1, 2014 · Terminated
The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)]…
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 CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL 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. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures
- 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 double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures)
- Lot codes and dates
84 of 84 products
Products covered by this recall # Barcodes Product as published 1 3661522016527Item reference: 73P20B , Batch number: 1902 , Expiration date: 09/2018 , GTIN on box label: 3661522016527 2 3661522016527Item reference: 73P20B , Batch number: 987180 , Expiration date: 07/2018 , GTIN on box label: 3661522016527 3 3661522016527Item reference: 73P20B , Batch number: 997390 , Expiration date: 08/2018 , GTIN on box label: 3661522016527 4 3661522016701Item reference: 73P30AA , Batch number: 932870 , Expiration date: 02/2018 , GTIN on box label: 3661522016701 5 3661522029510Item reference: 73P30AG , Batch number: 931880 , Expiration date: 12/2017 , GTIN on box label: 3661522029510 6 3661522029510Item reference: 73P30AG , Batch number: 932880 , Expiration date: 01/2018 , GTIN on box label: 3661522029510 7 3661522029510Item reference: 73P30AG , Batch number: 952490 , Expiration date: 03/2018 , GTIN on box label: 3661522029510 8 3661522029510Item reference: 73P30AG , Batch number: 954720 , Expiration date: 04/2018 , GTIN on box label: 3661522029510 9 3661522029510Item reference: 73P30AG , Batch number: 961280 , Expiration date: 06/2018 , GTIN on box label: 3661522029510 10 3661522029510Item reference: 73P30AG , Batch number: 967610 , Expiration date: 07/2018 , GTIN on box label: 3661522029510 11 3661522029510Item reference: 73P30AG , Batch number: 967620 , Expiration date: 10/2018 , GTIN on box label: 3661522029510 12 3661522029510Item reference: 73P30AG , Batch number: E04258 , Expiration date: 12/2018 , GTIN on box label: 3661522029510 13 3661522016923Item reference: 73P30AI , Batch number: 2415 , Expiration date: 10/2018 , GTIN on box label: 3661522016923 14 3661522016923Item reference: 73P30AI , Batch number: 911280 , Expiration date: 11/2017 , GTIN on box label: 3661522016923 15 3661522016923Item reference: 73P30AI , Batch number: 953070 , Expiration date: 03/2018 , GTIN on box label: 3661522016923 16 3661522016923Item reference: 73P30AI , Batch number: 997980 , Expiration date: 09/2018 , GTIN on box label: 3661522016923 17 3661522024348Item reference: 73P30AM , Batch number: 5006 , Expiration date: 01/2019 , GTIN on box label: 3661522024348 18 3661522024348Item reference: 73P30AM , Batch number: 913570 , Expiration date: 12/2017 , GTIN on box label: 3661522024348 19 3661522024256Item reference: 73P30AN , Batch number: 4282 , Expiration date: 12/2018 , GTIN on box label: 3661522024256 20 3661522024256Item reference: 73P30AN , Batch number: 904700 , Expiration date: 12/2017 , GTIN on box label: 3661522024256 - Amount recalled
- 4,976 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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