Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 F...
FDA Device Recall #Z-1051-2023 — Class II — January 4, 2023
Recall Summary
| Recall Number | Z-1051-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 4, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bard Peripheral Vascular Inc |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 7520 (Breakdown: US 3764; OUS 3243) |
Product Description
Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit
Reason for Recall
Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
Distribution Pattern
Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; OUS (foreign) countries of: Australia, Belgium, Canada, Hong Kong and Japan. O.U.S.: Australia, Belgium, Canada, Hong Kong, and Japan.
Lot / Code Information
Catalog Numbers/Lot-Serial Numbers/UDI Code: 0601610 / REFX4541 / (01)00801741036385(17)230930(10)REFX4541 0601610 / REFX5636 / (01)00801741036385(17)240930(10)REFX5636 0601610 / REFY2820 / (01)00801741036385(17)230930(10)REFY2820 0601610 / REGP0198 / (01)00801741036385(17)241231(10)REGP0198 0601610 / REGP2720 / (01)00801741036385(17)250131(10)REGP2720 0601610 / REGQ1144 / (01)00801741036385(17)250228(10)REGQ1144 0601620 / REES0680 / (01)00801741074479(17)230430(10)REES0680 0601620 / REEU0726 / (01)00801741074479(17)230630(10)REEU0726 0601620 / REEU1536 / (01)00801741074479(17)230630(10)REEU1536 0601620 / REEU3300 / (01)00801741074479(17)230630(10)REEU3300 0601620 / REEV1906 / (01)00801741074479(17)230731(10)REEV1906 0601620 / REFX4543 / (01)00801741074479(17)230930(10)REFX4543 0601630 / REEQ0746 / (01)00801741036408(17)230228(10)REEQ0746 0601630 / REGN2382 / (01)00801741036408(17)241231(10)REGN2382 0601630 / REGQ1143 / (01)00801741036408(17)250228(10)REGQ1143 0601680 / REER3749 / (01)00801741036415(17)230331(10)REER3749 0601680 / REEU1626 / (01)00801741036415(17)230630(10)REEU1626 0601690 / REES0716 / (01)00801741036422(17)230131(10)REES0716 0601690 / REFX1172 / (01)00801741036422(17)230131(10)REFX1172 0601690 / REFY0874 / (01)00801741036422(17)230131(10)REFY0874 0601700 / REES2549 / (01)00801741036439(17)230430(10)REES2549 0601700 / REGQ1154 / (01)00801741036439(17)230731(10)REGQ1154 0601710 / REFY2852 / (01)00801741036446(17)231031(10)REFY2852 0601730 / REGQ1174 / (01)00801741036453(17)240229(10)REGQ1174 0601740 / REFZ0223 / (01)00801741036460(17)230930(10)REFZ0223 0601750 / REFY0744 / (01)00801741036477(17)230731(10)REFY0744 0601760 / REEU1534 / (01)00801741036484(17)230630(10)REEU1534 0601790 / REFW1651 / (01)00801741036514(17)231031(10)REFW1651 7741700 / REET0877 / (01)00801741036798(17)240131(10)REET0877 7741800 / REER0703 / (01)00801741036804(17)240531(10)REER0703 7741800 / REFW3156 / (01)00801741036804(17)250131(10)REFW3156 0601600 / REES06790 / (01)00801741036378(17)220831(10)REES0679 0601600 / REES2528 / (01)00801741036378(17)220831(10)REES2528 0601600 / REES3456 / (01)00801741036378(17)220831(10)REES3456 0601610 / REEQ1683 / (01)00801741036385(17)220831(10)REEQ1683 0601610 / REEQ4180 / (01)00801741036385(17)220831(10)REEQ4180 0601610 / REER3748 / (01)00801741036385(17)220831(10)REER3748 0601610 / REES0715 / (01)00801741036385(17)220831(10)REES0715 0601610 / REET3287 / (01)00801741036385(17)220831(10)REET3287 0601620 / REEQ2751 / (01)00801741074479(17)220831(10)REEQ2751 0601620 / REEQ4141 / (01)00801741074479(17)220831(10)REEQ4141 0601620 / REER3694 / (01)00801741074479(17)220831(10)REER3694 0601620 / REET3269 / (01)00801741074479(17)220831(10)REET3269 0601630 / REEU0729 / (01)00801741036408(17)220831(10)REEU0729 0601630 / REEU3297 / (01)00801741036408(17)220831(10)REEU3297 0601690 / REEU0727 / (01)00801741036422(17)220831(10)REEU0727 0601700 / REER3695 / (01)00801741036439(17)220831(10)REER3695 0601710 / REER3750 / (01)00801741036446(17)220831(10)REER3750 0601710 / REEU3314 / (01)00801741036446(17)220831(10)REEU3314 0601740 / REEU3298 / (01)00801741036460(17)220831(10)REEU3298 0601750 / REEU0730 / (01)00801741036477(17)220831(10)REEU0730 0601750 / REEU1608 / (01)00801741036477(17)220831(10)REEU1608 0601760 / REER3696 / (01)00801741036484(17)220831(10)REER3696 0601760 / REES3457 / (01)00801741036484(17)220831(10)REES3457 0601760 / REET2794 / (01)00801741036484(17)220831(10)REET2794 0601760 / REEU1184 / (01)00801741036484(17)220831(10)REEU1184
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.