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Terminated

BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Foley Catheter, Waterproof underpad, Synthetic Vinyl Gloves (2), Lubricant, 10cc Syringe (prefilled with sterile water to inflate Foley catheter), Povidone-Iodine swabs (3), CSR Wrap, Plastic Tray. CR.Bard, Inc., Covington,GA 30014, 222.;bardmedical.com.

FDA Recall Z-0562-04 · Posted 2004-02-27

Recalling FirmC.R. Bard, Inc., Urological Division
Recall StatusTerminated
Product CodeKOD
Date Initiated2004-02-10
Date Terminated2004-07-09
Product Quantity1100 units (110 cases)

Reason for Recall

The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling.

Firm Action

Consignees were notified by certified mail on 02/10/2004.

Root Cause

Other

Distribution Pattern

AL, CA, CO, FL, GA, IL, IN, KY, MO, MS, NJ, NY, OH, PA, TX and WA.

Official Source

View FDA Recall →

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

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