FDA Medical Device Recalls (openFDA)
LeMaitre Vascular, Inc.: LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
- Recall number
- Z-1446-2017
- Recalling firm
- LeMaitre Vascular, Inc.
- Product
- LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU) REF# e2401-50
- Status
- Terminated
- Initiated
- 2017-02-07
- Posted
- not on file
- Terminated
- 2019-09-20
- Reason
- The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
- Root cause
- Labeling design
- Action
- LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced. Questions concerning this notice contact 781-221-2266 ext. 183.
- Quantity
- 4673
- Distribution
- Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
- Lot, serial or model codes
- Lot Number/Ex p. Date: RST2390 2018-08 RST2393 2018-09 RST2396 2018-10 RST2397 2018-10 RST2398 2018-10 RST2401 2018-12 RST2402 2018-12 RST2418 2019-02 RST2420 2019-03 RST2423 2019-03 RST2428 2019-04 RST2432 2019-04 RST2433 2019-04 RST2437 2019-06 RST2438 2019-06 RST2441 2019-07
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQO
- 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