Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling container fill and transfer sets because they cannot 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 is classified as FDA Class II, and the hazard involves a medical device failing to meet accuracy specifications, which poses a risk of harm without reported injuries, fitting the 'High' severity criteria.
Plain-English summary
The Metrix Company is voluntarily recalling Container fill and transfer sets in 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL sizes. The recall involves 137,598 cases of the product. The issue was identified after a redesign of the auto compounding device, which revealed that the compounder cannot meet the designed accuracy specification when dispensing into bags.
Upon reviewing the initial design, it was determined that dispensing volume validation was not properly conducted. Consequently, none of the compounders on the market can meet the stated specifications. The product was distributed to medical facilities in 21 US states and internationally to Australia, Canada, the Dominican Republic, Malaysia, Turkey, and the United Kingdom.
All lots are being recalled. The lot code consists of a five-digit product code followed by a dash and a unique five-character numeric or alphanumeric sequence. Affected product codes include 58781, 58785, 62005, 62010, 62015, 62025, 62030, 62035, 64005, 64010, 64015, 64025, 64030, 64035, 64781, 65005, 65010, 65015, 65025, 65030, 65035, 66005, 66010, 66015, 66020, 66025, 66030, 66035, 66305, 66310, 66315, 66325, 66330, 66335, 66705, 66710, 66715, 66725, 66730, 66735, 66910, 66915, 66925, 66930, 66935, 67005, 67010, 67015, 67025, 67030, 67035, 69005, 69010, 69015, 69025, 69030, and 69035.
The recalled product
- Product
- Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
- Manufacturer
- The Metrix Company
- Affected units
- 137,598
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 (20)
- 58785
- 62005
- 62010
- 62015
- 62025
- 62030
- 62035
- 64005
- 64010
- 64015
- 64025
- 64030
- 64035
- 64781
- 65005
- 65010
- 65015
- 65025
- 65030
- 65035
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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