Reported Aug 3, 2016 · Terminated
AUTOCOMP6 XP High Speed Compounder REF 58810
The Metrix Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Metrix Company · 4400 Chavenelle Rd · Dubuque, IA · 52002-2655
Is this the product you have?
- AUTOCOMP6 XP High Speed Compounder REF 58810
- Lot codes and dates
99 of 99 codes
000100020003000400050006000700080009001000110012001300140015001600170018001900200021002200230024002500260027002800290030003100320033003400350036003700380039004000410042004300440045004600470048004900500051005200530054005500560057005800590060
- Amount recalled
- 93 devices
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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