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 SM Ablation Catheter Item Numbers 210001SM 218501SM 210002SM 218502SM 210003SM 218503SM 210004SM 218504SM 210005SM 218505SM 210006SM 218506SM 210007SM 218507SM 210015SM 218516SM 210016SM 218518SM 210017SM 218519SM 210018SM 218520SM 210019SM 218521SM 210020SM 218523SM 210023SM 218524SM 210024SM 218525SM 210025SM 218526SM 210026SM 218527SM 210027SM 218528SM 210028SM 218529SM 210029SM 210030SM

FDA Recall Z-0601-03 · Posted 2003-02-28

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

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.

↑