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BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drain...

FDA Recall #Z-1357-2016 — Class II — December 18, 2015

Recall #Z-1357-2016 Date: December 18, 2015 Classification: Class II Status: Terminated

Product Description

BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Reason for Recall

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

Recalling Firm

C.R. Bard, Inc. — Covington, GA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1,428,000 units (total)

Distribution

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

Code Information

Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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