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

Bard Stinger Ablation Catheter: Item Numbers 210001 218501 L210001 210002 218502 L210002 210003 218503 L210003 210004 218504 L210004 210005 218505 L210005 210006 218506 L210006 210007 218507 L210007 210015 218516 L210008 210016 218518 L210009 210017 218519 L210010 210018 218520 L210011 210019 218521 L210012 210020 218523 L210013 210023 218524 L210014 210024 218525 L210015 210025 218526 L210016 210026 218527 L210017 210027 218528 L210018 210028 218529 210029 210030

FDA Recall Z-0598-03 · Posted 2003-02-28

Recalling FirmC. R.Bard, Inc./Electrophysiology Division
Recall StatusTerminated
Date Initiated2003-01-08
Date Terminated2012-05-03
Product Quantity18,706 units

Reason for Recall

Sterile barrier maybe perforated compromising sterility of the device

Firm Action

Bard Electrophysiology notified direct accounts by letter on 1.08.03 via Fed''X. Accounts are requested to return product.

Root Cause

Packaging process control

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

↑