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Terminated

Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.

FDA Recall Z-1431-2021 · Posted None

Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeKOD
Date Initiated2021-01-11
Date Terminated2023-02-02
Product Quantity9,800 Units

Reason for Recall

The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.

Firm Action

All customers will be contacted via letters sent via Fed Ex. The acknowledgement form included with the letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement. BD is requesting that customers discard affected components.

Root Cause

Packaging process control

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K802665TOUCHLESS CLEAN-CATHDiamed Division Ill. Tool Works, Inc. · 1980-11-12

Official Source

View FDA Recall →

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

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