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
Bronchoscope accessory - Product Code KTI
원인
Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.
조치
Acclarent sent an "Urgent Voluntary Product Recall" letter dated January 31, 2012 by US mail, return receipt requested to all affected customers. Additionally, customers known to have scheduled procedures using the affected product were notified by phone to advise them of the recall. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, discontinue use and return any remaining in stock per the instructions provided. The letter provides additional information and photographs illustrating how to identify the recalled product. Customers were advised to complete the enclosed Business Reply Card regardless of whether they have or do not have product subject to this recall in their possession and mail to Stericycle. Customers were instructed to distribute this information to all staff within their department who uses the affected product. For further questions call 1-866-781-1173 or contact your Acclarent Sales Representative.
Product code BC1840A, Size 18 x 40: Lot 110307E, Exp 3/2013; Lot 110429E, Exp 4/2013; Lot 110502B, Exp 5/2013; Lot 110506B, Exp 5/2013; Lot 110606B, Exp 6/2013; Lot 110614B, Exp 6/2013.
Nationwide Distribution (USA) only sixe 18 x 40 Worldwide distribution other sizes.Distirbution to France, Canada, Saudi Arabia
제품 설명
Inspira AIR Balloon Dilation System, || size 18 x 40; || Manufactured by Acclarent, Inc. || 1525-G O'Brien Drive, Menlo Park, CA 94025 || Product Usage: Dilation of airway tree.