Medical device recalls Moderate risk

Becton Dickinson & Company recalls PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00…

Recall date
June 19, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2661-2020
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

PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (UDI 00801741175718), CPA00055 UDI 00801741182181), CPA00056 (UDI 00801741182907)

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