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Devices
Device Recall BardiaComplete Foley Kit
Model / Serial
Catalog Number: 800518, Lot Number: 76IN0317
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
AL, CA, CO, FL, GA, IL, IN, KY, MO, MS, NJ, NY, OH, PA, TX and WA.
Product Description
Bardia¿Complete 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.
Manufacturer
C.R. Bard, Inc., Urological Division
1 Event
Recall of Device Recall BardiaComplete Foley Kit
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Manufacturer
C.R. Bard, Inc., Urological Division
Manufacturer Address
C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd Ne, Covington GA 30014-1497
Source
USFDA
Language
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