Recall Z-1144-03 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
C.R. Bard, Inc., Urological Division
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 d
| Date | Aug 21, 2003 (initiated Aug 29, 2002) |
| Status | Terminated |
| Reason | On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports. |
| Root cause | Other |
| 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. |
| Quantity | 1461 units |
| Distribution | The product was distributed nationwide, Canada, Belgium and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER Bard Medical Div., Feb 16, 1999 |