MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 14mm/42 Fr
This recall has been terminated (originally issued May 15, 2003).
- Company
- Boston Scientific Corporation
- Recall Initiated
- April 29, 2003
- Posted
- May 15, 2003
- Terminated
- March 11, 2004
- Recall Number
- Z-0831-03
- Quantity
- 9 units
- Firm Location
- Natick, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Catheter may be mislabeled
Distribution
CA, CO, IL, FL, HI, KY, LA, MA, ME, MI, NC, OH, PA, SC, TN, UT, VA, WA, WV,
Lot / Code Info
Catalog Number: 8914 Lot Number: 5465675
Root Cause
Other
Action Taken
The firm notified each direct account by letter on 4/29/03 and, via letters of July 3 and July 11, 2003, extended the recall to three additional sizes of the catheter . Users were requested to check inventory, return the products to Boston Scientific and to reply regarding receipt of recall notification and the return of products.