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.
Reported: December 4, 2019 Initiated: December 7, 2018 #Z-0576-2020
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.
Details
- Recalling Firm
- Spectranetics Corporation
- Units Affected
- 3 catheters
- Distribution
- Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Spectranetics Corporation. Units affected: 3 catheters.
Why was this product recalled? ▼
The incorrect outer carton box was used for the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0576-2020.
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