AUTOCOMP6 XPS High Speed Compounder REF 58810
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-2257-2016
- Quantity
- 16 devices
- 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
000001, 003002, 003003, 003004, 003005, 003006, 003007, 003008, 003009, 003010, 003011, 003012, 003013, 003014, 003015, 003016, 003017, 003018, 003019, 003020, 003023, 003024, 003025, 003026, 003027, 003028, 003029, 003030, 003031, 003036, 003037, 003038, 003039, 003040, 003041, 003042, 003043, 003044, 003045, 003046, 003047, 003048, 003049, 003050, 003051, 003052, 003053, 003054, 003055, 003056, 003057
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.