Device 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).
Z-0852-2019
Product summary
- Event
- Event 81863
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-0852-2019
Official wording
Reason: A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Code information: Material Number (UPN) H749M3004A0, Batch Number 21558994, Expiration Date 11/30/2019
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.
Derived failure modes
-
Labeling or packaging
incorrectly labeled