LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
FDA Device Recall #Z-0792-2022 — Class II — January 20, 2022
Recall Summary
| Recall Number | Z-0792-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 20, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bard Peripheral Vascular Inc |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 116,770 devices |
Product Description
LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
Reason for Recall
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Distribution Pattern
U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
Lot / Code Information
Catalog Number: 4301C Lot Numbers/UDI (GTIN, DI + PI): 0001410711 (01)10885403057038(17)220331(10)0001410711 0001411299 (01)10885403057038(17)220331(10)0001411299 0001411867 (01)10885403057038(17)220331(10)0001411867 0001414258 (01)10885403057038(17)220331(10)0001414258 0001414358 (01)10885403057038(17)220331(10)0001414358 0001414359 (01)10885403057038(17)220331(10)0001414359 0001415031 (01)10885403057038(17)220430(10)0001415031 0001415038 (01)10885403057038(17)220430(10)0001415038 0001415850 (01)10885403057038(17)220430(10)0001415850 0001415809 (01)10885403057038(17)220430(10)0001415809 0001417243 (01)10885403057038(17)220430(10)0001417243 0001417244 (01)10885403057038(17)220430(10)0001417244 0001417734 (01)10885403057038(17)220430(10)0001417734 0001418034 (01)10885403057038(17)220430(10)0001418034 0001418308 (01)10885403057038(17)220430(10)0001418308 0001418410 (01)10885403057038(17)220430(10)0001418410 0001421652 (01)10885403057038(17)220630(10)0001421652 0001421921 (01)10885403057038(17)220630(10)0001421921 0001422197 (01)10885403057038(17)220630(10)0001422197 0001422150 (01)10885403057038(17)220630(10)0001422150 0001422604 (01)10885403057038(17)220630(10)0001422604 0001425527 (01)10885403057038(17)220630(10)0001425527 0001425874 (01)10885403057038(17)220630(10)0001425874 0001426189 (01)10885403057038(17)220630(10)0001426189 0001426502 (01)10885403057038(17)220630(10)0001426502 0001427225 (01)10885403057038(17)220630(10)0001427225 0001427380 (01)10885403057038(17)220630(10)0001427380 0001429130 (01)10885403057038(17)220630(10)0001429130 0001429519 (01)10885403057038(17)220630(10)0001429519 0001430121 (01)10885403057038(17)220630(10)0001430121 0001430608 (01)10885403057038(17)220630(10)0001430608 0001431407 (01)10885403057038(17)220630(10)0001431407 0001431472 (01)10885403057038(17)220630(10)0001431472 0001432176 (01)10885403057038(17)220630(10)0001432176 0001432655 (01)10885403057038(17)220831(10)0001432655 0001433601 (01)10885403057038(17)220930(10)0001433601 0001433023 (01)10885403057038(17)220930(10)0001433023 0001434251 (01)10885403057038(17)220930(10)0001434251 0001434730 (01)10885403057038(17)220930(10)0001434730 0001436141 (01)10885403057038(17)220930(10)0001436141 0001437469 (01)10885403057038(17)221031(10)0001437469 0001437660 (01)10885403057038(17)221031(10)0001437660 0001437658 (01)10885403057038(17)221031(10)0001437658 0001437768 (01)10885403057038(17)221031(10)0001437768
Other Recalls from Bard Peripheral Vascular Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1367-2026 | Class II | Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown... | Dec 12, 2025 |
| Z-0887-2026 | Class II | Safe-T-Centesis 6 Fr Catheter Drainage Tray, RE... | Nov 6, 2025 |
| Z-2638-2025 | Class II | Venclose digiRF Generators, Model VCRFG1, with ... | Aug 21, 2025 |
| Z-1244-2025 | Class I | Rotarex Atherectomy System and Instructions for... | Feb 5, 2025 |
| Z-0467-2025 | Class II | Bard Marquee Disposable Core Biopsy Instrument ... | Sep 30, 2024 |
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.