FDA-Device2023-02-15Class II

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

Quest Medical, Inc.
Hazard

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

Sold states
US Nationwide distribution in the state of MA.
Affected count
13,900
Manufactured in
1 Allentown Pkwy, Allen, TX, United States
Products
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2023

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