Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Summary
The FDA issued a Class II for Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with by Quest Medical, Inc.. Reason: Delivery Sets may have tubing that could become detached that could result in patient infection..
Details
Source
Device Recall
External ID
Z-1100-2023
Action Date
2023-02-15
Status
Ongoing
Category
device
Product Description
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Lot/Code Info: REF/UDI-DI/Lots (Expiration Dates): PD06F/00634624911062/65824 (4/18/2025), 65826 (4/18/2025), 66069 (5/16/2025); PDT05CV2/00634624921412/66645 (7/11/2025)
Quantity Affected: 13,900
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-23
Company
Allen, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Quest Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Quest Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Quest Medical, Inc. have FDA actions?
Quest Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1100-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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