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U.S. Department of Health and Human Services

Class 2 Device Recall Stingray" Guidewire

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 Class 2 Device Recall Stingray" Guidewiresee related information
Date Initiated by FirmDecember 19, 2018
Create DateFebruary 20, 2019
Recall Status1 Terminated 3 on June 09, 2020
Recall NumberZ-0852-2019
Recall Event ID 81863
510(K)NumberK122795 
Product Classification Wire, guide, catheter - Product Code DQX
ProductStingray" 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
FEI Number 3002095335
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactNicole Pshon
763-494-1133
Manufacturer Reason
for Recall		A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
FDA Determined
Cause 2		Labeling mix-ups
ActionBoston 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 Commerce49 units
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = DQX
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