REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx O...
FDA Device Recall #Z-0812-2016 — Class III — January 4, 2016
Recall Summary
| Recall Number | Z-0812-2016 |
| Classification | Class III — Low risk |
| Date Initiated | January 4, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | C.R. Bard, Inc. |
| Location | Covington, GA |
| Product Type | Devices |
| Quantity | 15,400 units |
Product Description
REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.
Reason for Recall
Report by a customer of an open package seal.
Distribution Pattern
US Nationwide Distribution - in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico
Lot / Code Information
Lot Number NGZE1190
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.