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.
FDA Recall Z-1144-03 · Posted 2003-08-21
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Recalling FirmC.R. Bard, Inc., Urological Division
Recall StatusTerminated
Product CodeMJC
Date Initiated2002-08-29
Date Terminated2003-09-19
Product Quantity1461 units
Reason for Recall
On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.
Firm Action
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.
Root Cause
Other
Distribution Pattern
The product was distributed nationwide, Canada, Belgium and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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