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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Imager II Angiographic Catheter

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  Class 2 Device Recall Boston Scientific Imager II Angiographic Catheter see related information
Date Initiated by Firm December 15, 2016
Date Posted June 27, 2017
Recall Status1 Terminated 3 on April 10, 2018
Recall Number Z-2645-2017
Recall Event ID 76772
510(K)Number K121694  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
Code Information Lot: 00112758, Use by 2018-05-11
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
2 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer Reason
for Recall		 A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
FDA Determined
Cause 2		 Employee error
Action Customers were sent an Urgent Medical Device Removal letter, dated 12/15/2016, via overnight mail delivery beginning 12/15/2016. The letter identified affected product, described the issue, and asked for product to be returned. Removal instructions were provided and a Reply Verification Tracking Form was asked to be returned. Questions can be directed to Nicole Pshon, Field Action Manager at 763-494-1133 or BSCFieldActionCenter@bsci.com
Quantity in Commerce 39 boxes of 5 (195 units)
Distribution CA, FL, KY, MO, NM, OK, OR, PA, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = BOSTON SCIENTIFIC CORP.
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