Reported Dec 28, 2016 · Terminated
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to…
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
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: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. · 87 Venture Dr · Dover, NH · 03820-5914
Is this the product you have?
- AMS-651, 120" Microbore extension set with slide clamp
- Product CodeAMS-651
- Product UsageAccessory devices used to administer medical fluids
- Lot codes and dates
1601064D1603065D1605009D1606038D1607016D1607072D1608067D1609069D
- Amount recalled
- 31,500
Where it was sold
Why it was recalled
Incorrect priming volume is printed on the device package.
This product could cause temporary or reversible health problems — stop using it.
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