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Terminated

Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only)

FDA Recall Z-0603-03 · Posted 2003-02-28

Recalling FirmC. R.Bard, Inc./Electrophysiology Division
Recall StatusTerminated
Date Initiated2003-01-08
Date Terminated2012-05-03
Product Quantity12 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.

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