Z-2675-2014Class II

The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene...

Name: Z-2675-2014 The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene...
Creator: Peters Surgical
Published: 2014-06-25
License: https://open.fda.gov/license/

Peters Surgical / initiated 2014-06-25 / Terminated / root cause: manufacturing process

FDA source

Peters Surgical began a recall of The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different... on 2014-06-25. FDA classified it as Class II and gives the reason as "A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2675-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-25
Posted: 2014-09-22
Terminated: 2017-12-13
Recalling firm: Peters Surgical
Product: 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).
Product code: GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Reason for recall: A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The sole US distributor (MedAlliance Inc.) was notified of the recall via e-mail on July 16, 2014. IMPORTANT AND URGENT - BATCH RECALL PROCEDURE letters dated June 25, 2014 under the Peters Surgical header were sent to all MedAlliance Inc. consignees. The letters included instructions for consignees to contact MedAlliance Inc. by phone (630-933-8661) or by e-mail ([email protected]) for information on what to do with the recalled products. Consignees were also notified that they can contact Peters Surgical directly at [email protected] for answers to any additional questions. MedAlliance Inc. sent VOLUNTARY PRODUCT RECALL/WITHDRAWAL LETTER[s] dated June 25, 2014 to all consignees. The letters included instructions for consignees to: 1) discontinue use of and segregate recalled product in a secure location for return to MedAlliance Inc., and 2) to complete and return the enclosed RETURNED GOOD AUTHORIZATION (RGA) FORM to MedAlliance Inc. to arrange for the return of the recalled products. Consignees with any questions about the recall can contact Ms. Alaina Goos, Senior Product Manager, by phone at 630-933-8661 x 104 or via e-mail at [email protected].
Quantity in commerce: 4,976 units
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2675-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2675-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-22
Z-2676-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-22

Product code GAT

K060163Class IICardioflon, CardioxylPeters Surgical / cleared 2006-10-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)