FDA (Devices) recall action 74043
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The Metrix Company is recalling container fill and transfer sets because they may not meet designed accuracy specifications when dispensing into bags.
The Metrix Company is recalling container fill and transfer sets because they cannot meet designed accuracy specifications when dispensing into bags.
The Metrix Company is recalling Dual Chamber Containers because the associated auto-compounding device cannot meet accuracy specifications when dispensing into the bags.
The Metrix Company is recalling 250 mL and 500 mL container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications when dispensing into bags.
The Metrix Company is recalling 16 AUTOCOMP6 XPS High Speed Compounders because they cannot meet designed accuracy specifications when dispensing into bags.
The Metrix Company is recalling 323 AUTOCOMP6 High Speed Compounders because the devices cannot meet designed accuracy specifications when dispensing into bags.
The Metrix Company is recalling 93 AUTOCOMP6 XP High Speed Compounders because they cannot meet designed accuracy specifications when dispensing into bags.
The Metrix Company is recalling Dual Chamber Container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications for dispensing volume.