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Terminated

AUTOCOMP6 High Speed Compounder

FDA Recall Z-2259-2016 · Posted None

Recalling FirmThe Metrix Company
Recall StatusTerminated
Product CodeNEP
Date Initiated2016-06-23
Date Terminated2023-04-11
Product Quantity323

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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