Z-3226-2017 Class II Terminated
FDA device recall Z-3226-2017 was initiated by C.R. Bard, Inc. on July 28, 2017 and is designated Class II. Reason for recall: Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating. The recall status is terminated (terminated August 25, 2020). Affected quantity: 45,270 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 4, 2017
- Initiation Date
- July 28, 2017
- Termination Date
- August 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,270 units
Product Description
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.
Reason for Recall
Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.
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.
Code Information
Catalog No. 51514; Lot No. 53623024, 53623054, 53623047, 53623122; Exp Date 01/31/2020