Recall Z-2264-2016— The Metrix Company
Class II · Terminated
Class II FDA medical device recall by The Metrix Company, initiated 2016-06-23, terminated 2023-04-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Container fill and transfer sets, 250 mL and 500 mL, . .. Reason: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications..
- Recalling firm
- The Metrix Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-23
- Terminated
- 2023-04-11
- Firm location
- Dubuque, IA, United States
Product description
Container fill and transfer sets, 250 mL and 500 mL, . .
Reason for recall
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.