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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

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 Class 2 Recall
Quick Shield with Snappy Safety Holder
see related information
Date Posted November 09, 2011
Recall Number Z-0179-2012
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
Reason for
Recall
Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.
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.
 
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