Peters Surgical: Medical Device Recall in 2014 - (Recall #: Z-2675-2014)

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: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).

Class II

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

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

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

Voluntary: Firm initiated