Z-2198-2008

Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen...

Name: Z-2198-2008 Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen...
Creator: Greiner Bio-One North America, Inc.
Published: 2008-08-05
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2008-08-05 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through... on 2008-08-05. The reason FDA records is "At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out". 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-2198-2008
Status: Terminated
Initiated: 2008-08-05
Posted: 2008-09-30
Terminated: 2012-07-25
Recalling firm: Greiner Bio-One North America, Inc.
Product: Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Consignees were notified by letter on 08/06/2008. Letters to Distributors instructed them to stop distribution of the affected product immediately and to hold any product of the lots they may have pending returned to Greiner bio-one. The were instructed to provide Greiner bio-one with a list of their customers who may have received the affected lot so that they can contact them. A Product Disposition form was included to be completed and returned to Greiner bio-one. Contact Greiner Bio-One North America, Inc. at 1-888-286-3883 for assistance.
Quantity in commerce: 150,000 pcs
Distribution: AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV.
Product codes and lots: Lot#: A030804

Product code FMI

K980768Class IIVacuette HoldexGreiner Meditech, Inc. / cleared 1998-04-09

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)