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U.S. Department of Health and Human Services

Class 2 Device Recall Quick Shield with Snappy Safety Holder

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 Class 2 Recall
Quick Shield with Snappy Safety Holder
see related information
Date Posted November 09, 2011
Recall Status1 Terminated on March 20, 2012
Recall Number Z-0179-2012
Recall Event ID 59918
Premarket Notification
510(K) Number
K102774 
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.
Code Information Item #450254, Lot numbers: B041104, B051105 and B071106.
Recalling Firm/
Manufacturer
Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe, North Carolina 28110
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Manfred Abel
704-261-7800
Manufacturer Reason
for Recall
Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Greiner Bio-One sent a "QUICKSHIELD WITH SAFETY HOLDER" notification letter dated August 11, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to stop distributing and using the affected products. A Product Disposition Form was attached for customers to complete and return for replacements. Contact the firm at 888-266-3883 for questions concerning this recall.
Quantity in Commerce 443,950 pieces
Distribution Nationwide Distribution-USA (nationwide) including the states of CO, IL, KY, NY, PA 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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