AUTOCOMP6 XPS High Speed Compounder recall
AUTOCOMP6 XPS High Speed Compounder REF 58810
Why was AUTOCOMP6 XPS High Speed Compounder recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- AUTOCOMP6 XPS High Speed Compounder REF 58810
- Recalling firm
- The Metrix Company
- Quantity
- 16 devices
- 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
- Recall date
- August 3, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)