Events

Device Recall Medela Enteral Syringe, Acacia Piston Syringe 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medela Inc. EF Division 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
    70544
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1262-2015
  • 사례 시작날짜
    2015-02-13
  • 사례 출판 날짜
    2015-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134006
  • 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
    Syringe, piston - Product Code FMF
  • 원인
    The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.
  • 조치
    Medela sent a Device Recall letter dated February 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Requested Action of Distributors: 1. Stop sale and distribution of product with affected lot numbers. 2. Conduct a physical count and record the data on the Product Inventory Form included with the letter. 3. Return the Product Inventory Form via fax to 800-995-7867 or e-mail it to syringe@medela.com. The firm should contain a contact name and signature. 4. If have the affected product in stock, Medela Customer Service will issue a RMA and schedule a pick-up of the affected product. Contact will be made to ensure product is ready. For further questions please call (888) 399-2455.

Device

Device Recall Medela Enteral Syringe, Acacia Piston Syringe
  • 모델명 / 제조번호(시리얼번호)
    NTL-30 G0556, G0561, G0572, G0585, G0593, G0601, G0610, G0614, G0622, G0634, G0644, G0649, G0653, G0662, G0667, G0672, G0683, G0684, G0685, G0698, G0705, G0708, G0711, G0712, G0714, G0716, G0723, G0719, G0726, G0734, G0744, G0750, G0752, G0760  NTL-60 G0554, G0566, G0578, G0594, G0598, G0612, G0615, G0623, G0626, G0636, G0639, G0650, G0657, G0658, G0659, G0665, G0668, G0670, G0671, G0673, G0679, G0680, G0686, G0687, G0691, G0699, G0703, G0706, G0709, G0715, G0722, G0725, G0729, G0735, G0739, G0741, G0745, G0751, G0756, G0761  TL-INT-60 G0563, G0565, G0577, G0663, G0701, G0710, G0713, G0733, G0737, G0753  INT-60 G0555, G0567, G0575, G0587, G0591, G0603, G0620, G0638, G0640, G0648, G0664, G0690, G0718, G0746  NGF-60 G0550, G0560, G0568, G0576, G0592, G0609, G0628, G0646, G0655, G0675, G0688, G0697, G0707, G0724, G0730, G0728, G0743, G0754
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) || - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) || - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) || - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) || - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) || The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
  • Manufacturer
    Medela Inc. EF Division

Manufacturer

Medela Inc. EF Division
  • 제조사 주소
    Medela Inc. EF Division, 785 Challenger St, Brea CA 92821-2948
  • Source
    USFDA