Z-2675-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 1, 2014
- Initiation Date
- June 25, 2014
- Termination Date
- December 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,976 units
Product Description
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).
Reason for Recall
A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
Distribution Pattern
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
Code Information
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