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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientific Imager II Angiographic Catheter

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 Class 3 Recall
Boston Scientific Imager II Angiographic Catheter
see related information
Date Posted December 06, 2007
Recall Status1 Terminated on December 19, 2007
Recall Number Z-0279-2008
Recall Event ID 45432
Premarket Notification
510(K) Numbers
K011664  K050863 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland
Code Information Lot No: 48951
Recalling Firm/
Manufacturer
Boston Scientific Corporation
One Boston Scientific Place
Natick, Massachusetts 01760
Manufacturer Reason
for Recall
Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Boston Scientific sent an Urgent Medical Device Recall -- Immediate Action Required letter to consignees on 10/12/07. The letter described the product and the mislabeling problem (labeled outer carton and pouch as 4F when they are actually 5F devices). The firm recommended segregating the affected product and to return it to Boston Scientific PLEASE NOTE: The firm's recall letter incorrectly addressed the mislabeling of this product recall. The mislabeling involves the labeled outer carton and pouch were labeled as 5F when the device enclosed in the pouch was a 4F device.
Quantity in Commerce 14 boxes each containing 5 Units
Distribution USA only including states of NJ, CA,TX,AZ
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = BOSTON SCIENTIFIC CORP.
510(K)s with Product Code = DQO and Original Applicant = BOSTON SCIENTIFIC/MEDI-TECH
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