Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling container fill and transfer sets because they may not meet designed accuracy specifications when dispensing into bags.
What this means for you
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: The recall involves a medical device that fails to meet accuracy specifications, posing a risk of harm through incorrect dosing, but no injuries or illnesses have been reported.
Plain-English summary
The Metrix Company is recalling 18,366 cases of Container fill and transfer sets, automatic fill compatible, in sizes ranging from 250 mL to 4000 mL. The recall affects product codes 58740, 58741, 58742, 58749, 58750, 58753, and 58754.
The recall was initiated after a redesign of the auto compounding device revealed that the compounder 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.
The product was distributed to medical facilities in 21 US states and the US Virgin Islands, as well as 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
- Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
- Manufacturer
- The Metrix Company
- Hazard
- Affected units
- 18,366
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 (6)
- 58741
- 58742
- 58749
- 58750
- 58753
- 58754
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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