Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage,
FDA device recall Z-1499-06 · posted 2006-09-13 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.
- Action taken
- Consignee was notified via letter 8/10/06 to discontinue use of the product and to return it to the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- GBW
- Quantity affected
- 4 units
- Distribution
- Texas.
- Date initiated
- 2006-08-10
- Date posted
- 2006-09-13
- Date terminated
- 2007-02-07
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERCUTANEOUS DRAINING CATHETER (K811378) | Medi-Tech, Inc. | 1981-06-02 |