AUTOCOMP6 XP High Speed Compounder REF 58810
Reported: August 3, 2016 Initiated: June 23, 2016 #Z-2258-2016
Product Description
AUTOCOMP6 XP High Speed Compounder REF 58810
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.
Details
- Recalling Firm
- The Metrix Company
- Units Affected
- 93 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
- Location
- Dubuque, IA
Frequently Asked Questions
What product was recalled? ▼
AUTOCOMP6 XP High Speed Compounder REF 58810. Recalled by The Metrix Company. Units affected: 93 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2016. Severity: Moderate. Recall number: Z-2258-2016.
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