FDA recall Z-3226-2017

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.

Reason for recall

Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2017-07-28

Report date

2017-10-04

Termination date

2020-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3226-2017