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.
FDA Recall Z-0179-2012 · Posted 2011-11-09
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Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2011-08-11
Date Terminated2012-03-20
Product Quantity443,950 pieces
Reason for Recall
Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution-USA (nationwide) including the states of CO, IL, KY, NY, PA and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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