FDA-Device2012-07-11Class II
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
Greiner Bio-One North America, Inc.
Hazard
: The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.
Sold states
Nationwide Distribution including IL, MS, OH, PA, TN and VA.
Affected count
19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)
Manufactured in
4238 Capital Dr, N/A, Monroe, NC, United States
Products
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1935-2012Don't want to check this manually?
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