|
Class 3 Device Recall AngioSculpt PTCA Scoring Balloon Catheter |
|
Date Initiated by Firm |
November 13, 2007 |
Date Posted |
January 23, 2008 |
Recall Status1 |
Terminated 3 on March 25, 2008 |
Recall Number |
Z-0591-2008 |
Recall Event ID |
46149 |
PMA Number |
P050018 |
Product Classification |
Balloon Catheter - Product Code NWX
|
Product |
AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA. |
Code Information |
Lot Number: F07090015 |
Recalling Firm/ Manufacturer |
AngioScore Inc. 5055 Brandin Ct Fremont CA 94538-3140
|
For Additional Information Contact |
510-933-7904
|
Manufacturer Reason for Recall |
Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton
|
FDA Determined Cause 2 |
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 in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
PMA Database |
PMAs with Product Code = NWX and Original Applicant = SPECTRANETICS CORP.
|
|
|
|