Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-4015 , Product
FDA device recall Z-1115-03 · posted 2003-08-12 · Terminated
Recall details
- Recalling firm
- Boston Scientific Scimed
- Reason for recall
- Some of the product pouches have holes in the seals.
- Action taken
- Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
- Root cause
- Other
- Status
- Terminated
- Product code
- GBR
- Quantity affected
- 3
- Distribution
- The recalled products were shipped to hospitals located nationwide in the United States.
- Date initiated
- 2003-07-01
- Date posted
- 2003-08-12
- Date terminated
- 2006-12-28
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER (K021735) | Boston Scientific Scimed, Inc. | 2002-08-08 |