Rappel de Device Recall Peters Surgical CARDIOFLON Evolution

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Peters Surgical.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68721
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2676-2014
  • Date de mise en oeuvre de l'événement
    2014-06-25
  • Date de publication de l'événement
    2014-09-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2017-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
  • Cause
    A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
  • 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.

Device

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • 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
  • Description du dispositif
    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).
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Peters Surgical, 42 Rue Benoit Frachon, Bobigny France
  • Société-mère du fabricant (2017)
  • Source
    USFDA