Medical device recalls Moderate risk

Quest Medical, Inc. recalls Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2

Recall date
December 23, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1100-2023
FDA classification
Class II
Brand / firm
Quest Medical, Inc.
Sold / distributed
US Nationwide distribution in the state of MA.

Why it was recalled

Delivery Sets may have tubing that could become detached that could result in patient 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

Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2

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