Recall Z-2263-2016 ยท NEP System/Device, Pharmacy Compounding
The Metrix Company
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
| 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 | 18,474 case |
| 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
| K960581 | SECURE EVA DUAL CHAMBER MIXING BAG Secure Medical Products, Inc., Apr 30, 1996 |