Z-0179-2012

Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is...

Name: Z-0179-2012 Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is...
Creator: Greiner Bio-One North America, Inc.
Published: 2011-08-11
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2011-08-11 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of 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... on 2011-08-11. The reason FDA records is "Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0179-2012
Status: Terminated
Initiated: 2011-08-11
Posted: 2011-11-09
Terminated: 2012-03-20
Recalling firm: Greiner Bio-One North America, Inc.
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.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Item #450254, Lot numbers: B041104, B051105 and B071106.

Product code FMI

K102774Class IIVacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc. / cleared 2010-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)