FDA Medical Device Recalls (openFDA)
Lemaitre Vascular, Inc.: LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26
- Recall number
- Z-0557-05
- Recalling firm
- Lemaitre Vascular, Inc.
- Product
- LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26
- Status
- Terminated
- Initiated
- 2005-02-07
- Posted
- 2005-02-24
- Terminated
- 2005-07-25
- Reason
- Product sterility maybe compromised due to defective packaging
- Root cause
- Other
- Action
- LaMaitre notified consignees by lettter advising users to check inventory and return defective product.
- Quantity
- 100 units
- Distribution
- AL, CA, FL, IN, MD, MI,NY, TN, FOREIGN: Germany
- Lot, serial or model codes
- Lot Numbers: SLC1184
- 510(k) numbers
- ["K992368"]
- PMA numbers
- not on file
- Product code
- DXE
- Firm FEI
- 1220948
- Firm city
- Burlington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28