CLASS II Device recall · Reported 1 Oct 2014 · FDA Enforcement Report

The synthetic non-absorbable surgical sutures Cardioflon recalled

Peters Surgical is recalling The synthetic non-absorbable surgical sutures Cardioflon Evolution are composed of, distributed nationwide in the US. The recall was initiated on 25 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 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

Quantity recalled22,190 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2676-2014
FDA event ID: 68721
Recalling firm: Peters Surgical, Bobigny, N/A
Classification: Class II
Status: Terminated
Recall initiated: 25 Jun 2014
FDA classified: 22 Sep 2014
Reported: 1 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

25 Jun 2014	Recall initiated by company
22 Sep 2014	Classified by FDA	+89 days
1 Oct 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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).

Where it was distributed

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

Nationwide California Florida Georgia Illinois Indiana Louisiana Maryland Michigan Missouri Mississippi North Carolina New York Ohio Oregon Pennsylvania South Carolina Texas Virginia Washington

Questions about this recall

Is The synthetic non-absorbable surgical sutures Cardioflon Evolution are composed of recalled?

Yes. Peters Surgical recalled The synthetic non-absorbable surgical sutures Cardioflon Evolution are composed of on 25 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-2676-2014.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Peters Surgical

All 2

Reported	Class	Recall	Company	Reason	Where
1 Oct 2014Device	CLASS II	The synthetic non-absorbable surgical sutures Cardioxyl are recalled	Peters Surgical	Packaging Defects	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide