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 Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex Model: 1601-38

FDA Recall Z-0558-05 · Posted 2005-02-24

Recalling FirmLemaitre Vascular, Inc.
Recall StatusTerminated
Product CodeDXE
Date Initiated2005-02-07
Date Terminated2005-07-25
Product Quantity692 units

Reason for Recall

Product sterility maybe compromised due to defective packaging

Firm Action

LaMaitre notified consignees by lettter advising users to check inventory and return defective product.

Root Cause

Other

Distribution Pattern

AL, CA, FL, IN, MD, MI,NY, TN, FOREIGN: Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992368LEMAITRE EMBOLECTOMY CATHETERVascutech, Inc. · 1999-12-09

Official Source

View FDA Recall →

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

↑