LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml , Length 80 cm Latex Product Number: 1601-28
FDA device recall Z-0561-05 · 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
- 312 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
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