Precision Delivery IV Extension Set recallZ-1100-2023 · Quest Medical, Inc. · initiated Dec 23, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Quest Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Delivery Sets may have tubing that could become detached that could result in patient infection.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1100-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 23, 2022
- Posted by the FDA
- Feb 7, 2023
- Recalling firm
- Quest Medical, Inc.
- Quantity
- 13,900
- Product code
- FPA
- FDA submissions
- K202672
- Distribution
- US Nationwide distribution in the state of MA.
Product description
Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Code information (models, lots, serial numbers)
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)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Precision Delivery IV Extension Set PDT05CV2Quest Medical Inc · Set, Administration, Intravascular1 recall5 reports
- Precision Delivery IV Extension Set PD06FQuest Medical Inc · Set, Administration, Intravascular1 recall4 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K202672 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Precision Delivery IV Extension Set, Amber PDTV05FAQuest Medical Inc · Set, Administration, Intravascular6 reports
- Precision Delivery IV Extension Set, Amber PDV60FAQuest Medical Inc · Set, Administration, Intravascular6 reports
- Precision Delivery IV Extension Set PDB05CV1Quest Medical Inc · Set, Administration, Intravascular3 reports
- Precision Delivery Trifurcated IV Extension Set PDTV05FQuest Medical Inc · Set, Administration, Intravascular2 reports
- Precision Delivery Trifurcated IV Extension Set PDT05DFQuest Medical Inc · Set, Administration, Intravascular1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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