Metrix Dual Chamber Container Fill and Transfer Sets Recalled for Accuracy Issues
The Metrix Company is recalling Dual Chamber Container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications for dispensing volume.
What this means for you
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, which typically corresponds to a moderate severity level where the use of the product may cause temporary or medically reversible health consequences. No specific injuries or illnesses are reported in the source text, and the issue relates to a failure to meet accuracy specifications rather than a direct safety hazard like contamination or structural failure.
Plain-English summary
The Metrix Company is recalling 3,829 cases of Dual Chamber Container fill and transfer sets, available in 250 mL / 1250 mL or 500 mL / 2500 mL configurations. The recall affects product codes 58733 and 58734, with all lots of these codes being recalled.
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 performed, and none of the compounders on the market can meet the stated specifications.
The product was distributed to medical facilities in the United States, including states such as Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, and Washington. It was also distributed internationally to Australia, Canada, the Dominican Republic, Malaysia, Turkey, and the United Kingdom. Medical facilities should stop using the affected product and contact The Metrix Company for further instructions.
The recalled product
- Product
- Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL
- Manufacturer
- The Metrix Company
- Affected units
- 3,829
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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