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Terminated

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

FDA Recall Z-0599-03 · Posted 2003-02-28

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.

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