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Class 2 Device Recall Peters Surgical CARDIOXYL |
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| Date Initiated by Firm |
June 25, 2014 |
| Date Posted |
September 22, 2014 |
| Recall Status1 |
Terminated 3 on December 13, 2017 |
| Recall Number |
Z-2675-2014 |
| Recall Event ID |
68721 |
| 510(K)Number |
K060163
|
| Product Classification |
Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
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| 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). |
| 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 |
Recalling Firm/
Manufacturer |
Peters Surgical
42 Rue Benoit Frachon
Bobigny France
|
| For Additional Information Contact |
Ms. Alaina Goos
630-933-8661 Ext. 104
|
Manufacturer Reason
for Recall |
A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
|
FDA Determined
Cause 2 |
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 (agoos@medalliancesolutions.com) for information on what to do with the recalled products. Consignees were also notified that they can contact Peters Surgical directly at qualite@peters-surgical.com 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 agoos@medalliancesolutions.com. |
| 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 |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database |
510(K)s with Product Code = GAT and Original Applicant = PETERS SURGICAL
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