Device product
Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
Z-3226-2017
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 78031
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45,270 units
- Official record key
device-enforcement:Z-3226-2017
Official wording
Reason: Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.
Code information: Catalog No. 51514; Lot No. 53623024, 53623054, 53623047, 53623122; Exp Date 01/31/2020
Distribution pattern: Distribution to AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA.
Derived failure modes
-
Unknown
Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.