FDA Medical Device Recalls (openFDA)
LeMaitre Vascular, Inc.: LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
- Recall number
- Z-0473-2019
- Recalling firm
- LeMaitre Vascular, Inc.
- Product
- LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
- Status
- Terminated
- Initiated
- 2018-10-01
- Posted
- not on file
- Terminated
- 2020-04-10
- Reason
- Pouches from this lot are not sealed compromising the sterility
- Root cause
- Packaging process control
- Action
- Lemaitre Vascular initiated recall by letter on October 1, 2018, provided with reason for recall action to be taken, risk to health. Complete the enclosed customer reply form, and return it to LeMaitre Vascular, Inc. Return all devices from lot PFP1055, whether they appear to be unsealed or not. If you distributed any affected product to other facilities, please forward this recall to the recipients. Contact Information: rlerer@lemaitre.com 781-425-1671 Monday through Friday, 8:00 AM to 4:30 PM,
- Quantity
- 46 units
- Distribution
- FL Foreign: Austalia, Korea
- Lot, serial or model codes
- LOT# PFP1055 Expiration Date: 2020-03-28
- 510(k) numbers
- ["K152833"]
- PMA numbers
- not on file
- Product code
- MJN
- 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