AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremon
FDA device recall Z-0591-2008 · posted 2008-01-23 · Terminated
Recall details
- Recalling firm
- AngioScore Inc.
- Reason for recall
- Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton
- Action taken
- The firm initiated a field correction and issued Medical Device Field correction letters to its consignees on 11/09/2007, instructing consignees to review their inventory and return any mislabeled product or contact the firm.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NWX
- Quantity affected
- 40 units
- Distribution
- Nationwide-to 30 medical facilities in NC, SC, OH, IL, NY, PA, NJ, PA, LA, KS, FL, WI, MI, WA, and CA.
- Date initiated
- 2007-11-13
- Date posted
- 2008-01-23
- Date terminated
- 2008-03-25
- Location
- Fremont, CA
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