Z-2676-2014 Class II Terminated

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: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 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).

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

1) Item reference: 19P20Q , Batch number: 1135 , Expiration date: 10/2018 , GTIN on box label: 3661522034989 ; 2) Item reference: 19P30AC , Batch number: 942720 , Expiration date: 03/2018 , GTIN on box label: 3661522034446 ; 3) Item reference: 19P30AE , Batch number: 7627 , Expiration date: 04/2019 , GTIN on box label: 3661522034477 ; 4) Item reference: 19P30AE , Batch number: 942910 , Expiration date: 02/2018 , GTIN on box label: 3661522034477 ; 5) Item reference: 19P30AE , Batch number: 971670 , Expiration date: 05/2018 , GTIN on box label: 3661522034477 ; 6) Item reference: 19P30AK , Batch number: 942530 , Expiration date: 03/2018 , GTIN on box label: 3661522034552 ; 7) Item reference: 19P30AK , Batch number: 978580 , Expiration date: 06/2018 , GTIN on box label: 3661522034552 ; 8) Item reference: 19P30AN , Batch number: 942500 , Expiration date: 02/2018 , GTIN on box label: 3661522034576 ; 9) Item reference: 19P30AQ , Batch number: 2480 , Expiration date: 10/2018 , GTIN on box label: 3661522034606 ; 10) Item reference: 19P30AQ , Batch number: 5508 , Expiration date: 02/2019 , GTIN on box label: 3661522034606 ; 11) Item reference: 19P30AQ , Batch number: 994990 , Expiration date: 07/2018 , GTIN on box label: 3661522034606 ; 12) Item reference: 19P30AQ , Batch number: 1008710 , Expiration date: 08/2018 , GTIN on box label: 3661522034606 ; 13) Item reference: 19P30N , Batch number: 942420 , Expiration date: 02/2018 , GTIN on box label: 3661522034262 ; 14) Item reference: 19P30R , Batch number: 4370 , Expiration date: 01/2019 , GTIN on box label: 3661522034279 ; 15) Item reference: 19P30R , Batch number: 5021 , Expiration date: 01/2019 , GTIN on box label: 3661522034279 ; 16) Item reference: 19P30R , Batch number: 5557 , Expiration date: 02/2019 , GTIN on box label: 3661522034279 ; 17) Item reference: 19P30R , Batch number: 948700 , Expiration date: 03/2018 , GTIN on box label: 3661522034279 ; 18) Item reference: 19P30R , Batch number: 978410 , Expiration date: 06/2018 , GTIN on box label: 3661522034279 ; 19) Item reference: 19P30S , Batch number: 994580 , Expiration date: 07/2018 , GTIN on box label: 3661522034323 ; 20) Item reference: 19P30T , Batch number: 4371 , Expiration date: 01/2019 , GTIN on box label: 3661522034347 ; 21) Item reference: 19P30T , Batch number: 4974 , Expiration date: 02/2019 , GTIN on box label: 3661522034347 ; 22) Item reference: 19P30T , Batch number: 948740 , Expiration date: 03/2018 , GTIN on box label: 3661522034347 ; 23) Item reference: 19P30U , Batch number: 948770 , Expiration date: 03/2018 , GTIN on box label: 3661522034354 ; 24) Item reference: 19P30V , Batch number: 4372 , Expiration date: 01/2019 , GTIN on box label: 3661522034286 ; 25) Item reference: 19P30V , Batch number: 948790 , Expiration date: 03/2018 , GTIN on box label: 3661522034286 ; 26) Item reference: 19P30V , Batch number: 992210 , Expiration date: 07/2018 , GTIN on box label: 3661522034286 ; 27) Item reference: 19P30X , Batch number: 967150 , Expiration date: 05/2018 , GTIN on box label: 3661522034392 ; 28) Item reference: 19P30X , Batch number: 999390 , Expiration date: 09/2018 , GTIN on box label: 3661522034392 ; 29) Item reference: 19S15A , Batch number: 2192 , Expiration date: 10/2018 , GTIN on box label: 3661522035009 ; 30) Item reference: 19S15G , Batch number: 2195 , Expiration date: 10/2018 , GTIN on box label: 3661522035061 ; 31) Item reference: 19S15G , Batch number: 2440 , Expiration date: 10/2018 , GTIN on box label: 3661522035061 ; 32) Item reference: 19S15G , Batch number: 942960 , Expiration date: 02/2018 , GTIN on box label: 3661522035061 ; 33) Item reference: 19S15G , Batch number: 970060 , Expiration date: 05/2018 , GTIN on box label: 3661522035061 ; 34) Item reference: 19S15G , Batch number: 982470 , Expiration date: 06/2018 , GTIN on box label: 3661522035061 ; 35) Item reference: 19S15G , Batch number: 994930 , Expiration date: 07/2018 , GTIN on box label: 3661522035061 ; 36) Item reference: 19S20J , Batch number: 942940 , Expiration date: 05/2018 , GTIN on box label: 3661522034910 ; 37) Item reference: 19S20J , Batch number: 966100 , Expiration date: 08/2018 , GTIN on box label: 3661522034910 ; 38) Item reference: 19S20R , Batch number: 1872 , Expiration date: 09/2018 , GTIN on box label: 3661522037539 ; 39) Item reference: 19S30AB , Batch number: 7057 , Expiration date: 04/2019 , GTIN on box label: 3661522034439 ; 40) Item reference: 19S30AB , Batch number: 991250 , Expiration date: 07/2018 , GTIN on box label: 3661522034439 ; 41) Item reference: 19S30AB , Batch number: 999910 , Expiration date: 08/2018 , GTIN on box label: 3661522034439 ; 42) Item reference: 19S30AE , Batch number: 942400 , Expiration date: 03/2018 , GTIN on box label: 3661522034460 ; 43) Item reference: 19S30AE , Batch number: 984600 , Expiration date: 06/2018 , GTIN on box label: 3661522034460 ; 44) Item reference: 19S30AK , Batch number: 942510 , Expiration date: 02/2018 , GTIN on box label: 3661522034538 ; 45) Item reference: 19S30AK , Batch number: 992600 , Expiration date: 07/2018 , GTIN on box label: 3661522034538 ; 46) Item reference: 19S30AK , Batch number: 1011370 , Expiration date: 09/2018 , GTIN on box label: 3661522034538 ; 47) Item reference: 19S30AQ , Batch number: 942580 , Expiration date: 03/2018 , GTIN on box label: 3661522034590 ; 48) Item reference: 19S30AW , Batch number: 1485 , Expiration date: 09/2018 , GTIN on box label: 3661522037492 ; 49) Item reference: 19S30AX , Batch number: 1486 , Expiration date: 09/2018 , GTIN on box label: 3661522037508 ; 50) Item reference: 19S30AY , Batch number: 1487 , Expiration date: 09/2018 , GTIN on box label: 3661522037515 ; 51) Item reference: 19S30B , Batch number: 3403 , Expiration date: 01/2019 , GTIN on box label: 3661522034118 ; 52) Item reference: 19S30B , Batch number: 5136 , Expiration date: 02/2019 , GTIN on box label: 3661522034118 ; 53) Item reference: 19S30B , Batch number: 6222 , Expiration date: 02/2019 , GTIN on box label: 3661522034118 ; 54) Item reference: 19S30B , Batch number: 942350 , Expiration date: 03/2018 , GTIN on box label: 3661522034118 ; 55) Item reference: 19S30B , Batch number: 1009510 , Expiration date: 08/2018 , GTIN on box label: 3661522034118 ; 56) Item reference: 19S30C , Batch number: 3995 , Expiration date: 01/2019 , GTIN on box label: 3661522034125 ; 57) Item reference: 19S30C , Batch number: 4920 , Expiration date: 01/2019 , GTIN on box label: 3661522034125 ; 58) Item reference: 19S30C , Batch number: 5158 , Expiration date: 02/2019 , GTIN on box label: 3661522034125 ; 59) Item reference: 19S30C , Batch number: 6554 , Expiration date: 03/2019 , GTIN on box label: 3661522034125 ; 60) Item reference: 19S30C , Batch number: 977760 , Expiration date: 06/2018 , GTIN on box label: 3661522034125 ; 61) Item reference: 19S30C , Batch number: 988910 , Expiration date: 07/2018 , GTIN on box label: 3661522034125 ; 62) Item reference: 19S30Z , Batch number: 942670 , Expiration date: 03/2018 , GTIN on box label: 3661522034415 ; 63) Item reference: 19S35A , Batch number: 942760 , Expiration date: 04/2018 , GTIN on box label: 3661522034675