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

Hem-o-lok Endo5 Ligation Applier

FDA Recall Z-0031-05 · Posted 2004-10-22

Recalling FirmWeck
Recall StatusTerminated
Product CodeHBT
Date Initiated2004-08-18
Date Terminated2005-01-31
Product Quantity119 units

Reason for Recall

The jaws may break during clip loading or clip application.

Firm Action

Consignees were notified via Federal Express (Domestic) and by email (International and Weck Sales Representatives).

Root Cause

Other

Distribution Pattern

Nationwide; Australia, Buenos Aires, Canada, France, Korea, New Zealand, Singapore.

Official Source

View FDA Recall →

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

↑