SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Num...
FDA Device Recall #Z-2669-2020 — Class II — June 19, 2020
Recall Summary
| Recall Number | Z-2669-2020 |
| 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 with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH-0032YN (UDI 00801741066238), LH-0033YN (UDI 00801741066252), LH-0034YN (UDI 00801741066276), LH-0035YN (UDI 00801741066290 ), LH-0036YN (UDI 00801741066313), LH-0037YN (UDI 00801741066337), LH-0038YN (UDI 00801741066351), LH-0039YN (UDI 00801741066313), LH-0040YN (UDI 00801741066399)
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 LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH-0032YN (UDI 00801741066238), LH-0033YN (UDI 00801741066252), LH-0034YN (UDI 00801741066276), LH-0035YN (UDI 00801741066290 ), LH-0036YN (UDI 00801741066313), LH-0037YN (UDI 00801741066337), LH-0038YN (UDI 00801741066351), LH-0039YN (UDI 00801741066313), LH-0040YN (UDI 00801741066399). Lot Numbers: ASDQF068 ASDRF001 ASDRF002 ASDRF003 ASDRF005 ASEPF018 ASEPF019 ASEPF020 ASEPF026 ASEQF008 ASEQF025 ASEQF030 ASEQF039 ASEQF041 ASCYF038 ASCYF097 ASDQF065 ASDQF066 ASDQF067 ASDWF061 ASDWF062 ASDWF063 ASDWF064 ASDWF065 ASEQF045 ASEQF046 ASCYF039 ASCYF065 ASCYF093 ASCZF007 ASCZF008 ASCZF018 ASCZF019 ASCZF041 ASCZF042 ASDNF026 ASDQF027 ASDQF029 ASDQF037 ASDQF043 ASDQF051 ASDQF061 ASDRF037 ASDYF011 ASDYF016 ASDYF024 ASDYF034 ASDYF045 ASDYF055 ASDYF064 ASDYF066 ASDYF075 ASDYF078 ASDYF087 ASDZF073 ASDZF077 ASDZF087 ASDZF094 ASENF004 ASENF009 ASENF020 ASENF040 ASENF056 ASENF071 ASENF077 ASENF078 ASENF086 ASENF087 ASENF088 ASENF089 ASEPF001 ASEPF002 ASEPF003 ASEPF004 ASEPF005 ASCYF025 ASCYF026 ASCYF027 ASCZF028 ASDPF030 ASDQF016 ASDQF019 ASDQF024 ASDRF036 ASDZF014 ASDZF019 ASDZF023 ASDZF034 ASDZF040 ASDZF044 ASDZF052 ASDZF059 ASDZF067 ASEQF056 ASEQF069 ASEQF075 ASEQF076 ASCXF016 ASCXF017 ASDQF007 ASDQF010 ASDQF013 ASERF021 ASCXF014 ASCXF015 ASDPF038 ASDPF039 ASEQF108 ASEQF109 ASEQF111 ASEQF117 ASEQF121 ASEQF126 ASCYF096 ASDWF083 ASDWF084 ASEQF044 ASDRF007 ASDRF008 ASEQF042 ASCYF008 ASCYF009 ASCYF095 ASCZF030 ASDPF031 ASDPF032 ASCYF003 ASCYF004 ASDPF036 ASDPF037 ASEQF085 ASEQF093 ASEQF094 ASEQF095 ASERF041 ASCYF002 ASCYF094 ASDPF040 ASDPF041 ASCXF011 ASDNF044 ASDNF045 ASEQF100 ASEQF101 ASEQF102 ASEQF103 ASEQF104 Additional Lot as of 9/11/20: ASEQF034
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.