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
This recall has been terminated (originally issued June 23, 2016).
- Company
- The Metrix Company
- Recall Initiated
- June 23, 2016
- Terminated
- April 11, 2023
- Recall Number
- Z-2263-2016
- Quantity
- 18,474 case
- Firm Location
- Dubuque, IA
- Official Source
- View on FDA website ↗
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.
Distribution
Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
Lot / Code Info
All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 66617, 66622, 66632, 66642, 69616, 69621, 69631, and 69641
Root Cause
Device Design
Action Taken
On 6/23/2016, the recalling firm sent written recall notices to their distributors and end users notifying them of the recall. Customers and consignees were instructed to not use the devices, locate and quarantine all affected devices, and to complete the response form.