—#158531

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.

FDA product code: MJC — Catheter, Urological (Antimicrobial) And Accessories
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K033477
Affected lot / code info: Catalog No. 51514; Lot No. 53623024, 53623054, 53623047, 53623122; Exp Date 01/31/2020

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

Customers were notified via letter on 07/28/2017. Instructions included to examine their inventory and identify affected product and notify customers if further distributed. Bard Medical Division asks that customers contact customer service at 1-800-526-4455 if any affected units do not meet their needs.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

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.

Timeline

Recall initiated: 2017-07-28
Terminated: 2020-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158531. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.