PlainRecalls
FDA Devices Moderate Class II Terminated

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)

Reported: July 29, 2020 Initiated: June 19, 2020 #Z-2669-2020

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.

Details

Units Affected
5,296,132 total
Distribution
Worldwide Distribution
Location
Franklin Lakes, NJ

Frequently Asked Questions

What product was recalled?
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). Recalled by Becton Dickinson & Company. Units affected: 5,296,132 total.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 29, 2020. Severity: Moderate. Recall number: Z-2669-2020.