| Date Initiated by Firm | July 01, 2003 |
|---|
| Date Posted | August 12, 2003 |
|---|
| Recall Status1 |
Terminated 3 on December 28, 2006 |
| Recall Number | Z-1099-03 |
|---|
| Recall Event ID |
26708 |
| 510(K)Number | K021735 |
|---|
| Product Classification |
unknown device name - Product Code GBR
|
| Product | Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-5020 |
|---|
| Code Information |
Lot numbers 5458926, 5459705, 5462880, 5464053, 5523106, 5570556, 5576584, and 5581120 |
Recalling Firm/
Manufacturer |
Boston Scientific Scimed
One Scimed Place
Maple Grove MN 55311-1566
|
| For Additional Information Contact | Patrick Burt
763-494-1192 |
|---|
Manufacturer Reason
for Recall | Some of the product pouches have holes in the seals. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them. |
|---|
| Quantity in Commerce | 114 |
|---|
| Distribution | The recalled products were shipped to hospitals located nationwide in the United States. |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = GBR
|
|---|
