Precision Delivery Sets recalled due to potential tubing detachment
Quest Medical recalls Precision Delivery Sets (models PD06F and PDT05CV2) due to tubing that may detach, potentially causing patient infection. Approximately 13,900 units were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: No illnesses or injuries have been reported, and the hazard is theoretical. This meets the rubric criterion 'risk-of-harm products where injury has not yet been reported,' warranting a High severity (3) score.
Plain-English summary
Quest Medical, Inc. is recalling Precision Delivery Sets, including model PD06F (Precision Delivery Set with Filter) and model PDT05CV2 (Precision Delivery Set with Trifurcated Luer). These delivery sets may have tubing that could become detached, potentially resulting in patient infection.
Approximately 13,900 units have been distributed nationwide. The affected lots include: for PD06F, lots 65824 and 65826 (expiring 4/18/2025) and lot 66069 (expiring 5/16/2025); for PDT05CV2, lot 66645 (expiring 7/11/2025).
Patients and healthcare providers using these delivery sets should be aware of this recall. Anyone with questions about the recall or who has experienced issues related to product use should contact Quest Medical, Inc.
The recalled product
- Product
- Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
- Manufacturer
- Quest Medical, Inc.
- Category
- Medical Device
- Affected units
- 13,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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)
Distribution
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