FDA Device recall Z-2668-2020

SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit

• FDA Device
• Class II
• terminated
• Published 2020-07-29

On 2020-07-29 the FDA classified a Class II recall of SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit by Becton Dickinson And, citing 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….

Read the official FDA Device notice

Product

SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2668-2020%22

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