🔍 RecallPedia

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).

Class I - Dangerous
🏥 Medical Devices Recalled: June 25, 2014 Peters Surgical Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Peters Surgical
Reason for Recall:
A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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).

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2676-2014

Related Recalls

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).

Peters Surgical

Class I - Dangerous

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

Jun 25, 2014 Surgical Instruments Nationwide View Details →