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.
- Recall Initiated
- August 29, 2002
- Posted
- August 21, 2003
- Terminated
- September 19, 2003
- Recall Number
- Z-1144-03
- Quantity
- 1461 units
- Firm Location
- Covington, GA
Reason for Recall
On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.
Distribution
The product was distributed nationwide, Canada, Belgium and Germany.
Lot / Code Info
Catalog Number 6016L22 (all units packaged from January 1999 and shipped prior to September 2002).
Root Cause
Other
Action Taken
Consignees were notified by letter on 8/29/2002. They were advised to pretest the catheter prior to inserting the catheter into the urethra.If the pretest indicates that the catheter balloons do not inflate as labeled, they were advised not to use the product and to contact Bard Medical Division Field Assurance Manager to have the product returned and credited.
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