|
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
|
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
|
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
|
|
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.
|
|
|
|