Spectranetics AngioSculpt PTCA Scoring Balloon Catheter recall
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name…
Why was Spectranetics AngioSculpt PTCA Scoring Balloon Catheter recalled?
The incorrect outer carton box was used for the product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
AngioSculpt PTCA lot #G18090030.
- Product
- Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name…
- Recalling firm
- Spectranetics Corporation
- Quantity
- 3 catheters
- Distribution
- Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)