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Terminated

BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

FDA Recall Z-1359-2016 · Posted None

Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeMJC
Date Initiated2015-12-18
Date Terminated2016-06-29
Product Quantity1,428,000 units (total)

Reason for Recall

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

Firm Action

C. R. Bard, Inc. sent a "NOTIFICATION OF MISLABELING" letter, dated 12/18/2015 to all affected consignees. The letter identifies the product, problem, and actions to be taken by the customers.

Root Cause

Error in labeling

Distribution Pattern

Distributed US (nationwide) and the countries of Canada and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K910318BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETERC.R. Bard, Inc. · 1994-08-18

Official Source

View FDA Recall →

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

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