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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 Device Recall Quick Shield with Snappy Safety Holdersee related information
Date Initiated by FirmAugust 11, 2011
Date PostedNovember 09, 2011
Recall Status1 Terminated 3 on March 20, 2012
Recall NumberZ-0179-2012
Recall Event ID 59918
510(K)NumberK102774 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductQuick 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.
FEI Number 3001451379
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110
For Additional Information ContactManfred 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		Nonconforming Material/Component
ActionGreiner 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 Commerce443,950 pieces
DistributionNationwide Distribution-USA (nationwide) including the states of CO, IL, KY, NY, PA and VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMI
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