Recall Z-1357-2016
C.R. Bard, Inc. · initiated December 18, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
Codes / lots: Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.
Reason for recall
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-1357-2016
- Initiated
- December 18, 2015
- Terminated
- June 29, 2016
- Product code
- MJC – Catheter, Urological (Antimicrobial) And Accessories
- Quantity
- 1,428,000 units (total)
- Distribution
- Distributed US (nationwide) and the countries of Canada and Australia.
- Recalling firm
- C.R. Bard, Inc., Covington, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1358-2016 Class II | BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder…Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | 12/18/2015Terminated |
| Z-1359-2016 Class II | BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended…Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. | 12/18/2015Terminated |