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U.S. Department of Health and Human Services

Class 2 Device Recall Vacuette Quickshield Complete Plus

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 Class 2 Recall
Vacuette Quickshield Complete Plus
see related information
Date Posted July 03, 2012
Recall Status1 Terminated on February 27, 2013
Recall Number Z-1935-2012
Recall Event ID 62447
Premarket Notification
510(K) Number
K072320 
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
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.
Code Information Item #450239, Lot #G110601I and Item #450235, Lot #G110302J.
Recalling Firm/
Manufacturer
Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe, North Carolina 28110
For Additional Information Contact Manfred Abel
704-261-7823
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action greiner bio-one sent a notification letter dated April 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Product Disposition Site Confirmation form and fax to 800-726-0052 or email to patech@gbo.com. This form will confirm the affected product has been discarded/destroyed. The firm will replace the product after the completed form is returned to them. Customers with questions should call 800-515-8112. For questions regarding this recall call 704-261-7823.
Quantity in Commerce 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)
Distribution Nationwide Distribution including IL, MS, OH, PA, TN and VA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = GREINER BIO-ONE NORTH AMERICA, INC.
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