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The synthetic non-absorbable surgical sutures CARDIOFLON… recallZ-2676-2014 · Peters Surgical · initiated Jun 25, 2014

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Peters Surgical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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].

Recall details

Recall number
Z-2676-2014
Status
Terminated
Initiated by the company
Jun 25, 2014
Posted by the FDA
Sep 22, 2014
Recalling firm
Peters Surgical
Quantity
22,190 units
Product code
GAT
FDA submissions
K060163
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 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).

Code information (models, lots, serial numbers)

Show the full code information (7k characters)

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

Other devices under the same FDA submission

24 devices cleared under K060163 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 68721).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page