Quest Medical Recalls Q2 Multiport Intravenous Extension Sets
Quest Medical is recalling 17,700 Q2 Multiport Extension Sets distributed in the US and Canada. The nature of the defect is not detailed in available source documentation.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II designation indicates moderate severity. Without reported illnesses, injuries, or a specified hazard described in the available source, this appears to be a precautionary recall.
Plain-English summary
Quest Medical, Inc. is recalling Q2 Multiport Extension Sets (model REF 9520), which are sterile, single-use intravenous fluid administration sets. These devices feature a multiport IV manifold with integrated back-check valves and pre-attached needleless injection sites.
The recall affects 17,700 units distributed across multiple US states (Texas, Utah, Florida, California, Virginia, Colorado, Alabama, Nevada, Illinois, Oklahoma, Ohio, Pennsylvania, Missouri, Minnesota, Montana, Washington, Michigan, Tennessee, and New York) and Canada. Affected lot numbers are 69083, 69136, 69329, 69330, 69396, 69397, 69471, and 69472.
The source material provided does not specify the particular defect or hazard that prompted this recall. Affected patients, healthcare providers, and facilities should contact Quest Medical, Inc. for further information and guidance.
The recalled product
- Product
- Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.
- Manufacturer
- Quest Medical, Inc.
- Affected units
- 17,700
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 (9)
- Lots: 69083
- 69136
- 69329
- 69330
- 69396
- 69397
- 69471
- 69472
- UDI: (01)20634624952007
Distribution
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