Data Foundry

Medical device recalls 2020

SafeStep Huber Needle Set with Y Injection Site and Medegen… — Class II medical device recall Z-2669-2020

Terminated recall by Becton Dickinson & Company, reported 2020-07-29. Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that ha

Recall numberZ-2669-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson & Company, Franklin Lakes, NJ, United States
Recall initiated2020-06-19
Classified2020-07-18
Reported by FDA2020-07-29
Terminated2022-07-29
Quantity5,296,132 total
Reason classespackaging, device malfunction
UPC / GTIN / UDI-DI00801741066177, 00801741066191, 00801741066214, 00801741066238, 00801741066252, 00801741066276, 00801741066290, 00801741066313, 00801741066337, 00801741066351, 00801741066399
Lot numbersASCXF011, ASCXF014, ASCXF015, ASCXF016, ASCXF017, ASCYF002, ASCYF003, ASCYF004, ASCYF008, ASCYF009, ASCYF025, ASCYF026, ASCYF027, ASCYF038, ASCYF039, ASCYF065, ASCYF093, ASCYF094, ASCYF095, ASCYF096, ASCYF097, ASCZF007, ASCZF008, ASCZF018, ASCZF019, ASCZF028, ASCZF030, ASCZF041, ASCZF042, ASDNF026, ASDNF044, ASDNF045, ASDPF030, ASDPF031, ASDPF032, ASDPF036, ASDPF037, ASDPF038, ASDPF039, ASDPF040 and 108 more
Model numbersLH-0029YN

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2669-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.