International Medical Devices Database

Manufacturer Address
C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd NE, Covington GA 30014
Source
USFDA
2 Events
- Recall of Device Recall Bardex Lubricath
- Recall of Device Recall Bard DispozABag

2 devices in the database

Device Recall Bardex Lubricath

Model / Serial
Catalog Number 6016L22 (all units packaged from January 1999 and shipped prior to September 2002).
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
The product was distributed nationwide, Canada, Belgium and Germany.
Product Description
Bardex¿ Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon.

Device Recall Bard DispozABag

Model / Serial
Catalogue #150719, 150732, 150819, 150832, Lot numbers beginning with 76JL through 76BN.
Product Classification
Gastroenterology-Urology Devices
Device Class
1
Implanted device?
No
Distribution
Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.
Product Description
Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.

One manufacturer with a similar name

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C.R. Bard, Inc., Urological Division

Manufacturer Address
C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd Ne, Covington GA 30014-1497
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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