| Class 2 Device Recall IMAGER II Angiographic Catheters | |
Date Initiated by Firm | December 13, 2016 |
Date Posted | March 23, 2017 |
Recall Status1 |
Terminated 3 on November 22, 2017 |
Recall Number | Z-1781-2017 |
Recall Event ID |
76002 |
510(K)Number | K121694 |
Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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Product | Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN) |
Code Information |
Lot: 00116127, Expiration Date: September 30, 2018 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 2 Scimed Pl Maple Grove MN 55311-1565
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For Additional Information Contact | Nicole Pshon 763-494-1556 |
Manufacturer Reason for Recall | One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters. |
FDA Determined Cause 2 | Employee error |
Action | Customers were sent an Urgent Medical Device Removal letter, dated 12/5/2016, 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 | 26 boxes of 5 (130 singles) |
Distribution | AZ, FL, MO, NJ, NY, OH, PA, and TX. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DQO
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