—#150148

Product

Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter has an antibacterial and hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. It is packaged with a water sachet that is manually burst to hydrate the catheter coating at time of use. The catheters are packaged in a film-to-film pouch and are sterilized by electron beam irradiation and are distributed as a single use device. The catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction and surgical procedures. Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established. The device is not intended to be used as a treatment for active urinary tract infection. For urological use only; urinary catheters are intended for use for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.

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: Product Code: 53514, Lot number: 53622813, Exp. Date: 30Sep2017.

Why it was recalled

Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Bard Medical sent an Urgent Medical Device Product Recall letter dated October 5, 2016 to customers The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine and quarantine and return affected inventory. Customers were asked to complete and return the accompanying Recall & Effectiveness Check Form attached.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the states of: CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT.

Timeline

Recall initiated: 2016-10-05
Terminated: 2021-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150148. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.