Events

Device Recall Sterile Lubricating Jelly 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 H & P Industries, Inc. dba Triad Group 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
    57612
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0934-2011
  • 사례 시작날짜
    2010-12-23
  • 사례 출판 날짜
    2011-01-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96796
  • 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
    Lubricant, patient - Product Code KMJ
  • 원인
    Triad group is recalling all lots of sterile lubricating jelly manufactured by triad group. this recall has been initiated due to concerns expressed by the food and drug administration regarding the validation of the gamma radiation sterilization cycles for these products.
  • 조치
    The firm, Triad Group, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 22, 2010, to all customers via US Postal Service certified. The letter described the issue, identified affected product as that which contained a lot number beginning with the digits 7, 8, 9, or 0, and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall; notify their customers at once if the recalled product was further distributed, and complete and return the enclosed Recall Acknowledgement form via fax at 262-538-2947 or mail along with the recalled product to: Recall Coordinator, Triad Group, 700 West North Shore Drive, Hartland, WI 53029. If you have any questions, please call Triad Group Customer Service Monday thru Friday, between the hours of 8:30 a.m. and 4:00 p.m. Central Time at 262-538-2900 ext 2761.

Device

Device Recall Sterile Lubricating Jelly
  • 모델명 / 제조번호(시리얼번호)
    all Lot numbers beginning with the digits 7, 8, 9, or 0.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MO, MS, MY, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI and Puerto Rico; and countries including: Australia, Belgium, Canada, China, Lebanon, New Zealand, Philippines, Northern Marianna Islands, Saudi Arabia, Singapore, Taiwan, and United Arab Emirates.
  • 제품 설명
    Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packets || Intended use: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. || Brand names: || 1. Allegiance, Distributed by: Cardinal Health, McGaw Park, IL 60085-6787, USA, Cat. LJT2. Net Wt. 2 oz., Cat. LJF3, Net Wt. 3g, Cat. LJT4, Net Wt. 4 oz., Cat. LJT5, Net Wt. 5 g; || 2. Select medical products, manufactured for PSS World Medical, Inc., 4345 Southpoint Blvd., Jacksonville, FL 32216, Reorder #137, 3 g/packet, Reorder #136, 4 oz.; || 3. Novaplus, Manufactured for Novation, Inc., Irving, TX 75039, Manufactured by: Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, Cat. No. V10-8344, Net Wt. 3 grams, Cat. No. V10-8919, Net Wt. 4 oz., Cat. No. V10-8917, Net Wt. 2 oz.; || 4. Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, || Cat. No. 10-8917, Net Wt. 2 oz, || Cat. No. 10-8946, Net Wt. 5 g, || Triad Plus Cat. No. 11-8344, 3 g., || Cat. No. 11-8472, 5 grams, || Cat. No. 10-8919, Net Wt. 4 oz, || Cat. No. 10-8500, Net Wt. 4 oz; || 5. IMCO, Manufactured for: Independent Medical Co-op, Inc., Daytona Beach, FL 32114. Reorder No. 8919-IMC Net Wt. 4 oz.; || 6. McKesson Medi-Pak Performance, Marketed by McKesson Corporation, McKesson Surgical, Richmond, VA 23228. Reorder No. 66-8919, Net Wt. 4 oz.; || 7. Henry Schein, Distributed by: Henry Schein Inc., Melville, NY 11747. 104-9637, Net Wt. 4 fl. oz.
  • Manufacturer
    H & P Industries, Inc. dba Triad Group

Manufacturer

H & P Industries, Inc. dba Triad Group
  • 제조사 주소
    H & P Industries, Inc. dba Triad Group, 700 W North Shore Dr, Hartland WI 53029-8358
  • Source
    USFDA