Medical device recalls Moderate risk

Becton Dickinson & Company recalls SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)

Recall date
June 19, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2667-2020
FDA classification
Class II
Brand / firm
Becton Dickinson & Company
Sold / distributed
Worldwide Distribution

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)

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