Recall Z-0591-2008 ยท NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
AngioScore Inc.
AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.
| Date | Jan 23, 2008 (initiated Nov 13, 2007) |
| Status | Terminated |
| Reason | Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton |
| Root cause | Process control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.