Z-1935-2012Class II

Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is...

Name: Z-1935-2012 Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is...
Creator: Greiner Bio-One North America, Inc.
Published: 2012-04-02
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2012-04-02 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood... on 2012-04-02. FDA classified it as Class II and gives the reason as ": The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable". 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-1935-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-02
Posted: 2012-07-03
Terminated: 2013-02-27
Recalling firm: Greiner Bio-One North America, Inc.
Product: Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: greiner bio-one sent a notification letter dated April 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Product Disposition Site Confirmation form and fax to 800-726-0052 or email to [email protected]. This form will confirm the affected product has been discarded/destroyed. The firm will replace the product after the completed form is returned to them. Customers with questions should call 800-515-8112. For questions regarding this recall call 704-261-7823.
Quantity in commerce: 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total)
Distribution: Nationwide Distribution including IL, MS, OH, PA, TN and VA.
Product codes and lots: Item #450239, Lot #G110601I and Item #450235, Lot #G110302J.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1935-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1935-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-07-03

Product code FMI

K072320Class IIGreiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. / cleared 2007-09-14

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)