Z-2134-2008

Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with...

Name: Z-2134-2008 Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with...
Creator: Greiner Bio-One North America, Inc.
Published: 2008-05-16
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2008-05-16 / Terminated / root cause: design

FDA source

Greiner Bio-One North America, Inc. began a recall of Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a... on 2008-05-16. 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 design.

Recall record

Recall number: Z-2134-2008
Status: Terminated
Initiated: 2008-05-16
Posted: 2008-09-11
Terminated: 2009-08-21
Recalling firm: Greiner Bio-One North America, Inc.
Product: Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the holder. It is intended for use in routine specimen withdrawal from collection bags or bottles through needless 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: design
FDA root cause: Device Design
Action: Consignees were notified by letter on/about 05/16/2008. They were instructed to stop distributing the affected lots immediately and destroy any of the product they may have. A Product Disposition form was attached to be completed and returned via fax to Greiner bio-one. Consignees instructed to notify their customers and to provide Greiner bio-one with a list of their customers that have received the item. If you have any questions contact Manfred Abel at 704-261-7823.
Quantity in commerce: 1,606,005 units
Distribution: Class II Recall - Nationwide Distribution.
Product codes and lots: Item #450216, Lot #A10074, A100745, A100746, A100747, A110749, and A110750.

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)