Z-0852-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 27, 2019
- Initiation Date
- December 19, 2018
- Termination Date
- June 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product Description
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).
Reason for Recall
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Distribution Pattern
Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY.
Code Information
Material Number (UPN) H749M3004A0, Batch Number 21558994, Expiration Date 11/30/2019