FDAJune 19, 2020device

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 0080174...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

becton dickinsonbectonbecton dickinson

UPCs

008017410854820080174108549900801741085505008017410855120080174108552900801741085536008017410855430080174108555000801741085567008017410855740080174108558100801741085598

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 0080174... — Recall Details · AllClear