Spectranetics AngioSculpt Balloon Catheter Recalled for Incorrect Outer Carton
Spectranetics Corporation is recalling three AngioSculpt PTCA Scoring Balloon Catheters because the incorrect outer carton box was used for the product.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging-only problem (incorrect outer carton box) with no reported injuries or illnesses, fitting the 'Low' severity criteria for cosmetic or documentation issues.
Plain-English summary
Spectranetics Corporation is recalling three units of the AngioSculpt PTCA Scoring Balloon Catheter. The specific product affected is the balloon catheter with an outer diameter of 2.5mm and a length of 15mm, identified by reference number 2027-2515 and lot number G18090030. The recall is due to the use of an incorrect outer carton box for the product.
The affected units were distributed to Iowa, Michigan, and New Jersey. The distribution included government channels, but there was no military or foreign distribution. The product is a prescription medical device intended for sterile use.
Healthcare providers and facilities that may have received these specific units should stop using them and contact Spectranetics Corporation for further instructions. Consumers are not directly affected as this is a prescription medical device distributed through professional channels.
The recalled product
- 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.
- Manufacturer
- Spectranetics Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- AngioSculpt PTCA lot #G18090030.
Distribution
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