Recall Z-1359-2016 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
C.R. Bard, Inc.
BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
| Date | Dec 18, 2015 |
| Status | Terminated |
| Reason | Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. |
| Root cause | Error in labeling |
| Action | C. R. Bard, Inc. sent a "NOTIFICATION OF MISLABELING" letter, dated 12/18/2015 to all affected consignees. The letter identifies the product, problem, and actions to be taken by the customers. |
| Quantity | 1,428,000 units (total) |
| Distribution | Distributed US (nationwide) and the countries of Canada and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER C.R. Bard, Inc., Aug 18, 1994 |