Events

Device Recall Suture, nonabsorbable, synthetic, polyethylene. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Teleflex Medical 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    67733
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1292-2014
  • 사례 시작날짜
    2014-03-11
  • 사례 출판 날짜
    2014-03-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126181
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
  • 원인
    The products are being recalled because they did not meet minimum needle attachment strength requirements.
  • 조치
    Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990

Device

Device Recall Suture, nonabsorbable, synthetic, polyethylene.
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 0100019-507, Lot number: 02F1301128; Product Code: 6-511, Lot number: 02M0800561; Product Code: 6-559, Lot number: 02A0800005; Product Code: 69-403, Lot number: 02H0802530; Product Code: 7-5008M4, Lot number: 02C0900466; Product Code: 7-518, Lot number: 02E1302561; Product Code: 7-565, Lot number: 02B1100185; Product Code: 7-655A, Lot numbers: 02C0901963 & 02M0800836; Product Code: 7-740, Lot number: 02L1000536; Product Code: 833-114, Lot numbers: 02A1202112, 02C0903374 & 02D1202794; Product Code: 02F0902697, 02K1100404, 02L1202369 & 02M0802509; Product Code: E13-6351, Lot number: 02F0902446; Product Code: E13-6354, Lot number: 02F0902439; Product Code: E13-6399, Lot number: 02F0902436; Product Code: E6-545, Lot number: 02F0902443; Product Code: E7-4578, ot number: 02D0901672; Product Code: H5300, Lot number: 1450153E13; Product Code: RN6-5106M5, Lot number: 02F1003837; Product Code: RN7-536M5, Lot number: 02A0801205; Product Code: TEV100, Lot number: 02G1101500; Product Code: V-2599, Lot number: 02F0802055; Product Code: X-5424, Lot number: 02B0900765; Product Code: X6-692W, Lot number: 02C0803135; Product Code: X7-655M6A, Lot number: 02A0900806, 02A0902742, 02C0900446 & 02H1003233 and Product Code: XF7-7011, Lot numbers: 02A0901594.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
  • 제품 설명
    Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, || Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • 제조사 주소
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA