LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26
FDA device recall Z-0557-05 · posted 2005-02-24 · Terminated
Recall details
- Recalling firm
- Lemaitre Vascular, Inc.
- Reason for recall
- Product sterility maybe compromised due to defective packaging
- Action taken
- LaMaitre notified consignees by lettter advising users to check inventory and return defective product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 100 units
- Distribution
- AL, CA, FL, IN, MD, MI,NY, TN, FOREIGN: Germany
- Date initiated
- 2005-02-07
- Date posted
- 2005-02-24
- Date terminated
- 2005-07-25
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEMAITRE EMBOLECTOMY CATHETER (K992368) | Vascutech, Inc. | 1999-12-09 |