FDA recall Z-1100-2023

Quest Medical, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the state of MA.

Key facts

Status
Ongoing
Initiation date
2022-12-23
Report date
2023-02-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allen, TX, United States

Primary source

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