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Class 2 Device Recall Stingray" Guidewire |
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Date Initiated by Firm |
December 19, 2018 |
Create Date |
February 20, 2019 |
Recall Status1 |
Terminated 3 on June 09, 2020 |
Recall Number |
Z-0852-2019 |
Recall Event ID |
81863 |
510(K)Number |
K122795
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Product Classification |
Wire, guide, catheter - Product Code DQX
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Product |
Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). |
Code Information |
Material Number (UPN) H749M3004A0, Batch Number 21558994, Expiration Date 11/30/2019 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Scimed Pl Maple Grove MN 55311-1565
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For Additional Information Contact |
Nicole Pshon 763-494-1133
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Manufacturer Reason for Recall |
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Boston Scientific notified customers on about 12/19/2018 via "Urgent Medical Device Removal - Immediate Action Required" notice. Instructions included to immediately discontinue use of and segregate affected product, complete and return the Reply Verification Tracking Form to receive a RGA to return affected product, return all affected product, notify customers of the recall if product was further distributed. |
Quantity in Commerce |
49 units |
Distribution |
Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY. |
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 = DQX and Original Applicant = BRIDGEPOINT MEDICAL
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