Z-0576-2020 Class II Terminated
FDA device recall Z-0576-2020 was initiated by Spectranetics Corporation on December 7, 2018 and is designated Class II. Reason for recall: The incorrect outer carton box was used for the product. The recall status is terminated (terminated October 27, 2020). Affected quantity: 3 catheters.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- December 7, 2018
- Termination Date
- October 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 catheters
Product Description
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
Reason for Recall
The incorrect outer carton box was used for the product.
Distribution Pattern
Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.
Code Information
AngioSculpt PTCA lot #G18090030.