Recall Z-1935-2012— Greiner Bio-One North America, Inc.
Class II · Terminated
Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2012-04-02, terminated 2013-02-27. It names one FDA 510(k) clearance: K072320. Product: 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.. Reason: : 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..
- Recalling firm
- Greiner Bio-One North America, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-02
- Terminated
- 2013-02-27
- Firm location
- Monroe, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
: 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.