FDAClass IIOctober 1, 2014

The synthetic non-absorbable surgical sutures CARDIOXYL recall

The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of…

Why was The synthetic non-absorbable surgical sutures CARDIOXYL recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1) Item reference: 73P20B , Batch number: 1902 , Expiration date: 09/2018 , GTIN on box label: 3661522016527 ; 2) Item reference: 73P20B , Batch number: 987180 , Expiration date: 07/2018 , GTIN on box label: 3661522016527 ; 3) Item reference: 73P20B , Batch number: 997390 , Expiration date: 08/2018 , GTIN on box label: 3661522016527 ; 4) Item reference: 73P30AA , Batch number: 932870 , Expiration date: 02/2018 , GTIN on box label: 3661522016701 ; 5) Item reference: 73P30AG , Batch number: 931880 , Expiration date: 12/2017 , GTIN on box label: 3661522029510 ; 6) Item reference: 73P30AG , Batch number: 932880 , Expiration date: 01/2018 , GTIN on box label: 3661522029510 ; 7) Item reference: 73P30AG , Batch number: 952490 , Expiration date: 03/2018 , GTIN on box label: 3661522029510 ; 8) Item reference: 73P30AG , Batch number: 954720 , Expiration date: 04/2018 , GTIN on box label: 3661522029510 ; 9) Item reference: 73P30AG , Batch number: 961280 , Expiration date: 06/2018 , GTIN on box label: 3661522029510 ; 10) Item reference: 73P30AG , Batch number: 967610 , Expiration date: 07/2018 , GTIN on box label: 3661522029510 ; 11) Item reference: 73P30AG , Batch number: 967620 , Expiration date: 10/2018 , GTIN on box label: 3661522029510 ; 12) Item reference: 73P30AG , Batch number: E04258 , Expiration date: 12/2018 , GTIN on box label: 3661522029510 ; 13) Item reference: 73P30AI , Batch number: 2415 , Expiration date: 10/2018 , GTIN on box label: 3661522016923 ; 14) Item reference: 73P30AI , Batch number: 911280 , Expiration date: 11/2017 , GTIN on box label: 3661522016923 ; 15) Item reference: 73P30AI , Batch number: 953070 , Expiration date: 03/2018 , GTIN on box label: 3661522016923 ; 16) Item reference: 73P30AI , Batch number: 997980 , Expiration date: 09/2018 , GTIN on box label: 3661522016923 ; 17) Item reference: 73P30AM , Batch number: 5006 , Expiration date: 01/2019 , GTIN on box label: 3661522024348 ; 18) Item reference: 73P30AM , Batch number: 913570 , Expiration date: 12/2017 , GTIN on box label: 3661522024348 ; 19) Item reference: 73P30AN , Batch number: 4282 , Expiration date: 12/2018 , GTIN on box label: 3661522024256 ; 20) Item reference: 73P30AN , Batch number: 904700 , Expiration date: 12/2017 , GTIN on box label: 3661522024256 ; 21) Item reference: 73P30AN , Batch number: 961770 , Expiration date: 04/2018 , GTIN on box label: 3661522024256 ; 22) Item reference: 73P30AN , Batch number: 989950 , Expiration date: 08/2018 , GTIN on box label: 3661522024256 ; 23) Item reference: 73P30BQ , Batch number: 6068 , Expiration date: 02/2019 , GTIN on box label: 3661522030004 ; 24) Item reference: 73P30CN , Batch number: 5884 , Expiration date: 02/2019 , GTIN on box label: 3661522033265 ; 25) Item reference: 73P30CN , Batch number: 933320 , Expiration date: 01/2018 , GTIN on box label: 3661522033265 ; 26) Item reference: 73P30CN , Batch number: 950890 , Expiration date: 03/2018 , GTIN on box label: 3661522033265 ; 27) Item reference: 73P30CN , Batch number: 967120 , Expiration date: 05/2018 , GTIN on box label: 3661522033265 ; 28) Item reference: 73P30CN , Batch number: 967660 , Expiration date: 05/2018 , GTIN on box label: 3661522033265 ; 29) Item reference: 73P30CN , Batch number: 967670 , Expiration date: 07/2018 , GTIN on box label: 3661522033265 ; 30) Item reference: 73P30CN , Batch number: 967680 , Expiration date: 10/2018 , GTIN on box label: 3661522033265 ; 31) Item reference: 73P30CR , Batch number: 953110 , Expiration date: 03/2018 , GTIN on box label: 3661522033456 ; 32) Item reference: 73P30CR , Batch number: 967190 , Expiration date: 05/2018 , GTIN on box label: 3661522033456 ; 33) Item reference: 73P30CR , Batch number: 967490 , Expiration date: 05/2018 , GTIN on box label: 3661522033456 ; 34) Item reference: 73P30CR , Batch number: 967540 , Expiration date: 07/2018 , GTIN on box label: 3661522033456 ; 35) Item reference: 73P30CR , Batch number: 967550 , Expiration date: 10/2018 , GTIN on box label: 3661522033456 ; 36) Item reference: 73P30D , Batch number: 2965 , Expiration date: 11/2018 , GTIN on box label: 3661522011829 ; 37) Item reference: 73P30D , Batch number: 962430 , Expiration date: 03/2018 , GTIN on box label: 3661522011829 ; 38) Item reference: 73P30D , Batch number: 985250 , Expiration date: 07/2018 , GTIN on box label: 3661522011829 ; 39) Item reference: 73P30D , Batch number: 1002680 , Expiration date: 08/2018 , GTIN on box label: 3661522011829 ; 40) Item reference: 73P30E , Batch number: 352 , Expiration date: 11/2018 , GTIN on box label: 3661522011836 ; 41) Item reference: 73P30E , Batch number: 4145 , Expiration date: 02/2019 , GTIN on box label: 3661522011836 ; 42) Item reference: 73P30E , Batch number: 945250 , Expiration date: 03/2018 , GTIN on box label: 3661522011836 ; 43) Item reference: 73P30E , Batch number: 953660 , Expiration date: 04/2018 , GTIN on box label: 3661522011836 ; 44) Item reference: 73P30E , Batch number: 989250 , Expiration date: 07/2018 , GTIN on box label: 3661522011836 ; 45) Item reference: 73P30F , Batch number: 3845 , Expiration date: 12/2018 , GTIN on box label: 3661522011843 ; 46) Item reference: 73P30F , Batch number: 994880 , Expiration date: 07/2018 , GTIN on box label: 3661522011843 ; 47) Item reference: 73P30O , Batch number: 866 , Expiration date: 10/2018 , GTIN on box label: 3661522011904 ; 48) Item reference: 73P30O , Batch number: 4174 , Expiration date: 01/2019 , GTIN on box label: 3661522011904 ; 49) Item reference: 73P30O , Batch number: 911760 , Expiration date: 12/2017 , GTIN on box label: 3661522011904 ; 50) Item reference: 73P30O , Batch number: 923610 , Expiration date: 12/2017 , GTIN on box label: 3661522011904 ; 51) Item reference: 73P30O , Batch number: 994970 , Expiration date: 07/2018 , GTIN on box label: 3661522011904 ; 52) Item reference: 73P30P , Batch number: 1136 , Expiration date: 10/2018 , GTIN on box label: 3661522011911 ; 53) Item reference: 73P30P , Batch number: 4937 , Expiration date: 01/2019 , GTIN on box label: 3661522011911 ; 54) Item reference: 73P30Q , Batch number: 3426 , Expiration date: 11/2018 , GTIN on box label: 3661522011928 ; 55) Item reference: 73P30Q , Batch number: 933160 , Expiration date: 01/2018 , GTIN on box label: 3661522011928 ; 56) Item reference: 73P30Q , Batch number: 987680 , Expiration date: 07/2018 , GTIN on box label: 3661522011928 ; 57) Item reference: 73P30Q , Batch number: 990070 , Expiration date: 07/2018 , GTIN on box label: 3661522011928 ; 58) Item reference: 73P30Q , Batch number: 999820 , Expiration date: 10/2018 , GTIN on box label: 3661522011928 ; 59) Item reference: 73P30R , Batch number: 4114 , Expiration date: 01/2019 , GTIN on box label: 3661522011935 ; 60) Item reference: 73P30T , Batch number: 950930 , Expiration date: 03/2018 , GTIN on box label: 3661522011959 ; 61) Item reference: 73P30T , Batch number: 967130 , Expiration date: 05/2018 , GTIN on box label: 3661522011959 ; 62) Item reference: 73P30U , Batch number: 1543 , Expiration date: 09/2018 , GTIN on box label: 3661522014103 ; 63) Item reference: 73P30U , Batch number: 4168 , Expiration date: 02/2019 , GTIN on box label: 3661522014103 ; 64) Item reference: 73P30U , Batch number: 916660 , Expiration date: 12/2017 , GTIN on box label: 3661522014103 ; 65) Item reference: 73P30U , Batch number: 930430 , Expiration date: 12/2017 , GTIN on box label: 3661522014103 ; 66) Item reference: 73P30U , Batch number: 970800 , Expiration date: 05/2018 , GTIN on box label: 3661522014103 ; 67) Item reference: 73P30U , Batch number: 985280 , Expiration date: 07/2018 , GTIN on box label: 3661522014103 ; 68) Item reference: 73P30V , Batch number: 2446 , Expiration date: 10/2018 , GTIN on box label: 3661522014110 ; 69) Item reference: 73P30V , Batch number: 3656 , Expiration date: 11/2018 , GTIN on box label: 3661522014110 ; 70) Item reference: 73P30V , Batch number: 4126 , Expiration date: 01/2019 , GTIN on box label: 3661522014110 ; 71) Item reference: 73P30V , Batch number: 4127 , Expiration date: 03/2019 , GTIN on box label: 3661522014110 ; 72) Item reference: 73P30V , Batch number: 972030 , Expiration date: 05/2018 , GTIN on box label: 3661522014110 ; 73) Item reference: 73P30V , Batch number: 1007320 , Expiration date: 08/2018 , GTIN on box label: 3661522014110 ; 74) Item reference: 73P30U , Batch number: 970800 , Expiration date: 05/2018 , GTIN on box label: 3661522014103 ; 75) Item reference: 73P30U , Batch number: 985280 , Expiration date: 07/2018 , GTIN on box label: 3661522014103 ; 76) Item reference: 73P30Y , Batch number: 899000 , Expiration date: 11/2017 , GTIN on box label: 3661522016268 ; 77) Item reference: 73P30Y , Batch number: 915630 , Expiration date: 12/2017 , GTIN on box label: 3661522016268 ; 78) Item reference: 73P30Y , Batch number: 992250 , Expiration date: 07/2018 , GTIN on box label: 3661522016268 ; 79) Item reference: 73P35E , Batch number: 956930 , Expiration date: 04/2018 , GTIN on box label: 3661522024409 ; 80) Item reference: 73P35E , Batch number: 964930 , Expiration date: 05/2018 , GTIN on box label: 3661522024409 ; 81) Item reference: 73S10H , Batch number: 944410 , Expiration date: 02/2018 , GTIN on box label: 3661522029961 ; 82) Item reference: 73S10H , Batch number: 999710 , Expiration date: 08/2018 , GTIN on box label: 3661522029961 ; 83) Item reference: 73S30AE , Batch number: 938640 , Expiration date: 02/2018 , GTIN on box label: 3661522016466 ; 84) Item reference: 73S30AT , Batch number: 940360 , Expiration date: 02/2018 , GTIN on box label: 3661522021637

Product
The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of…
Recalling firm
Peters Surgical
Quantity
4,976 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, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, LEBANON, LIBYA, MALAYSIA, MAURITIUS, MOLDOVA, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NORTH KOREA, PAKISTAN, PERU, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, VENEZUELA, VIETNAM, YEMEN
Recall date
October 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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