Recall Z-1100-2023— Quest Medical, Inc.

Name: FDA recall Z-1100-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-23

Class II · Ongoing

Class II FDA medical device recall by Quest Medical, Inc., initiated 2022-12-23. It names one FDA 510(k) clearance: K202672. Product: Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2. Reason: Delivery Sets may have tubing that could become detached that could result in patient infection..

Recalling firm: Quest Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-23
Firm location: Allen, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K202672 — Precision Delivery Infusion SetQuest Medical, Inc.·cleared 2021-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.