C.R. Bard, Inc., Urological Division 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
C.R. Bard, Inc., Urological Division
Lot Codes / Batch Numbers
Catalog Number: 800518, Lot Number: 76IN0317
Products Sold
Catalog Number: 800518, Lot Number: 76IN0317
C.R. Bard, Inc., Urological Division is recalling BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800 due to The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling.
Recommended Action
Per FDA guidance
Consignees were notified by certified mail on 02/10/2004.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, FL, GA, IL, IN, KY, MS, MO, NJ, NY, OH, PA, TX, WA
Page updated: Jan 10, 2026