Recall Z-0576-2020— Spectranetics Corporation
Class II · Terminated
Class II FDA medical device recall by Spectranetics Corporation, initiated 2018-12-07, terminated 2020-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: The incorrect outer carton box was used for the product..
- Recalling firm
- Spectranetics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-07
- Terminated
- 2020-10-27
- Firm location
- Fremont, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.