Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, St
FDA device recall Z-1144-03 · posted 2003-08-21 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc., Urological Division
- Reason for recall
- On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MJC
- Quantity affected
- 1461 units
- Distribution
- The product was distributed nationwide, Canada, Belgium and Germany.
- Date initiated
- 2002-08-29
- Date posted
- 2003-08-21
- Date terminated
- 2003-09-19
- Location
- Covington, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARDEX LUBRI-SIL I.C. FOLEY CATHETER (K984136) | Bard Medical Div. | 1999-02-16 |