Recall Z-2260-2016 ยท NEP System/Device, Pharmacy Compounding
The Metrix Company
Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
| Date | Jun 23, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 137,598 cases |
| 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 K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030888 | EVA EMPTY SOLUTION CONTAINER Metrix Co., Apr 2, 2003 |