Metrix Dual Chamber Container Recall Due to Dispensing Accuracy Issues
The Metrix Company is recalling Dual Chamber Containers because the associated auto-compounding device cannot meet accuracy specifications when dispensing into the bags.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a failure to meet accuracy specifications, which fits the criteria for a moderate severity recall involving a quality defect without reported harm.
Plain-English summary
The Metrix Company is recalling 18,474 cases of Dual Chamber Containers fill with gravity/attached transfer sets. The affected products include various sizes such as 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, and 500 mL / 3500 mL. The recall covers all lots with product codes 66617, 66622, 66632, 66642, 69616, 69621, 69631, and 69641.
The recall was initiated after an issue was identified following a redesign of the auto-compounding device. It was determined that the compounder cannot meet the designed accuracy specification when dispensing into the bags. A review of the initial design revealed that dispensing volume validation was not properly conducted, and none of the compounders on the market can meet the stated specifications.
The product was distributed to medical facilities in 21 US states, including Alabama, Arizona, California, and Texas, as well as internationally to Australia, Canada, the Dominican Republic, Malaysia, Turkey, and the United Kingdom. Medical facilities should stop using the affected products and contact The Metrix Company for instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
- Manufacturer
- The Metrix Company
- Hazard
- Affected units
- 18,474
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 (7)
- 66622
- 66632
- 66642
- 69616
- 69621
- 69631
- and 69641
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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