Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product ...
FDA Device Recall #Z-0600-2017 — Class II — October 5, 2016
Recall Summary
| Recall Number | Z-0600-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 5, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | C.R. Bard, Inc. |
| Location | Covington, GA |
| Product Type | Devices |
| Quantity | 10,290 units |
Product Description
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.
Reason for Recall
Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).
Distribution Pattern
US Nationwide Distribution in the states of: CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT.
Lot / Code Information
Product Code: 53514, Lot number: 53622813, Exp. Date: 30Sep2017.
Other Recalls from C.R. Bard, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1431-2021 | Class II | Bard Clean-Cath Intermittent Catheter, 12 Frenc... | Jan 11, 2021 |
| Z-1355-2018 | Class II | Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0... | Feb 27, 2018 |
| Z-1357-2018 | Class II | Bard(R) Premature Infant Feeding tube, ENFit(TM... | Feb 27, 2018 |
| Z-1354-2018 | Class II | Bard(R) Premature Infant Feeding Tube, ENFit(TM... | Feb 27, 2018 |
| Z-1356-2018 | Class II | Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM)... | Feb 27, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.