Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10

FDA Recall Z-0473-2019 · Posted None

Recalling FirmLeMaitre Vascular, Inc.
Recall StatusTerminated
Product CodeMJN
Date Initiated2018-10-01
Date Terminated2020-04-10
Product Quantity46 units

Reason for Recall

Pouches from this lot are not sealed compromising the sterility

Firm 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: [email protected] 781-425-1671 Monday through Friday, 8:00 AM to 4:30 PM,

Root Cause

Packaging process control

Distribution Pattern

FL Foreign: Austalia, Korea

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152833Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc. · 2016-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑