Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling 250 mL and 500 mL container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications when dispensing into bags.
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional defect regarding dispensing accuracy rather than a direct safety hazard like contamination or structural failure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Metrix Company is recalling 1,350 cases of 250 mL and 500 mL container fill and transfer sets. The recall involves product codes 66505 and 66510. The product was distributed to medical facilities in 21 US states and Puerto Rico, as well as internationally to Australia, Canada, the Dominican Republic, Malaysia, Turkey, and the United Kingdom.
The recall was initiated after an issue was identified following a redesign of the auto compounding device. The device cannot meet the designed accuracy specification when dispensing into bags. A review of the initial design determined that dispensing volume validation was not properly conducted, and none of the compounders on the market can meet the stated specifications.
Medical facilities should stop using the affected product and contact The Metrix Company for further instructions. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- Container fill and transfer sets, 250 mL and 500 mL, . .
- Manufacturer
- The Metrix Company
- Hazard
- Affected units
- 1,350
Distribution
Part of a larger recall action
This product is one of 8 recalled by The Metrix Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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