Reported Mar 29, 2017 · Terminated
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
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-63660" Microbore extension set
- Product UsageAccessory devices used to administer medical fluids
- Lot codes and dates
- 1610092D 1611091D 1612068D 1612074D
- Amount recalled
- 30,700
Where it was sold
Why it was recalled
Incorrect priming volume printed on the device package.
This product could cause temporary or reversible health problems — stop using it.
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