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.
This recall has been terminated (originally issued February 27, 2004).
- Recall Initiated
- February 10, 2004
- Posted
- February 27, 2004
- Terminated
- July 9, 2004
- Recall Number
- Z-0562-04
- Quantity
- 1100 units (110 cases)
- Firm Location
- Covington, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling.
Distribution
AL, CA, CO, FL, GA, IL, IN, KY, MO, MS, NJ, NY, OH, PA, TX and WA.
Lot / Code Info
Catalog Number: 800518, Lot Number: 76IN0317
Root Cause
Other
Action Taken
Consignees were notified by certified mail on 02/10/2004.
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