SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029Y...
FDA Device Recall #Z-2666-2020 — Class II — June 19, 2020
Recall Summary
| Recall Number | Z-2666-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 19, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson & Company |
| Location | Franklin Lakes, NJ |
| Product Type | Devices |
| Quantity | 5,296,132 total |
Product Description
SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 00801741085550), PA-0033 (UDI 00801741085567), PA-0033YN (UDI 00801741085574), PA-0034 (UDI 00801741085581), PA-0034YN (UDI 00801741085598), PA-0036 (UDI 00801741085604), PA-0038 (UDI 00801741085628), PA-0038YN (UDI 00801741085635)
Reason for Recall
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Distribution Pattern
Worldwide Distribution
Lot / Code Information
Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 00801741085550), PA-0033 (UDI 00801741085567), PA-0033YN (UDI 00801741085574), PA-0034 (UDI 00801741085581), PA-0034YN (UDI 00801741085598), PA-0036 (UDI 00801741085604), PA-0038 (UDI 00801741085628), PA-0038YN (UDI 00801741085635). Lot Numbers: REDX2834 REDX4856 REDY1792 REDY2773 REEN2075 REEN4559 REEP1004 REEP3058 REEQ4021 REER0466 REER1235 REER2399 REDW3688 REDZ3026 REEN1109 REEP2916 REEQ2690 REEQ4063 REDS1399 REDS1875 REDS3371 REDS4425 REDT1836 REDU4512 REDX2861 REDY0778 REDY3542 REDZ3102 REEN1044 REEP3066 REEQ2648 REER2400 REDR1897 REDR2695 REDR2796 REDS1288 REDS1400 REDS2408 REDS4621 REDT0697 REDT1645 REDT1837 REDT2924 REDT4207 REDU2262 REDU2347 REDU3328 REDV1094 REDV1239 REDV2772 REDV2983 REDW0413 REDX3752 REDY1723 REDY3731 REDZ0146 REDZ1859 REDZ3027 REEN2076 REEN2144 REEN3136 REEP0964 REER2366 REER2367 REER2401 REDN3937 REDQ0732 REDQ1532 REDQ3957 REDS1850 REDS2265 REDT0698 REDT1646 REDT2747 REDT4188 REDU0781 REDU2263 REDV2200 REDV3476 REDW0549 REDX1497 REDX3753 REDZ1056 REDZ1761 REEN1110 REEN2794 REEN4560 REEP3956 REDY3732 REDZ1860 REEN2774 REEN4491 REEP1005 REEQ1672 REER1236 REDQ1535 REDR2696 REDR2795 REDS1857 REDS4422 REDT1838 REDT2744 REDZ1762 REEN1045 REEN2786 REEN4561 REEP2919 REEP4051 REEQ4065 REER1273 REDX0146 REDY0779 REEN2792 REEP0965 REDZ3028 REEN4492 REEP0983 REEQ0701 REEQ1660 REEQ4024 REER0454 REDW1196 REDY0780 REDZ3104 REER2354 REDX1373 REEP0984 REEQ4066 REER2388 REEN1048 REEN2077 REEQ0671 REDX1374 REDZ1065 REEN4562 REEP0942
Other Recalls from Becton Dickinson & Company
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1496-2026 | Class II | 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. ... | Jan 27, 2026 |
| Z-0504-2026 | Class II | BD Luer Tip Caps; Catalog Number(s) or Model N... | Oct 14, 2025 |
| Z-0736-2024 | Class II | PosiFlush Prefilled Saline Syringe with General... | Nov 16, 2023 |
| Z-0349-2024 | Class II | BD Alaris Pump infusion sets (Product Name, Cat... | Oct 11, 2023 |
| Z-0351-2024 | Class II | BD Extension Sets (Product Name, Catalog #) ... | Oct 11, 2023 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.