Recall Z-0600-2017
C.R. Bard, Inc. · initiated October 5, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product Code: 53514, Lot number: 53622813, Exp. Date: 30Sep2017.
Reason for recall
Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).
FDA-determined cause: Mixed-up of materials/components
Action taken
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.
Details
- Recall number
- Z-0600-2017
- Initiated
- October 5, 2016
- Terminated
- October 8, 2021
- Product code
- MJC – Catheter, Urological (Antimicrobial) And Accessories
- Quantity
- 10,290 units
- Distribution
- US Nationwide Distribution in the states of: CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT.
- Recalling firm
- C.R. Bard, Inc., Covington, GA