Z-1100-2023Class II

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

Name: Z-1100-2023 Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF...
Creator: Quest Medical, Inc.
Published: 2022-12-23
License: https://open.fda.gov/license/

Quest Medical, Inc / initiated 2022-12-23 / Open, Classified / root cause: manufacturing process

FDA source

Quest Medical, Inc. began a recall of Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2 on 2022-12-23. FDA classified it as Class II and gives the reason as "Delivery Sets may have tubing that could become detached that could result in patient infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1100-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-23
Posted: 2023-02-07
Recalling firm: Quest Medical, Inc
Product: Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Product code: FPA Set, Administration, Intravascular
Reason for recall: Delivery Sets may have tubing that could become detached that could result in patient infection.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 12/23/22, the recall notice was distributed. The customer was asked to return affected devices and to call 1-800-627-0226, extension 311, if they had any questions.
Quantity in commerce: 13,900
Distribution: US Nationwide distribution in the state of MA.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1100-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1100-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-07

Product code FPA

K202672Class IIPrecision Delivery Infusion SetQuest Medical, Inc. / cleared 2021-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)