Z-2957-2011

HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder...

Name: Z-2957-2011 HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder...
Creator: Greiner Bio-One North America, Inc.
Published: 2011-06-29
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2011-06-29 / Terminated

FDA source

Greiner Bio-One North America, Inc. began a recall of HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder with an off-center female luer at the top of the... on 2011-06-29. The reason FDA records is "At removal of the tube from the holder, the needle may dislodge and blood spill can occur". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2957-2011
Status: Terminated
Initiated: 2011-06-29
Posted: 2011-08-08
Terminated: 2011-11-03
Recalling firm: Greiner Bio-One North America, Inc.
Product: HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder, recommended for use with commercially available butterfly and luer needles in routine venipuncture procedures.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
FDA root cause: Other
Action: Greiner Bio-One North America, Inc. sent a "Recall HOLDEX Single Use Holder PP" letter dated June 29, 2011 to all affected customers. The letter instructed customers stop distributing the product immediately. A Product Disposition form was provided to be completed and returned to Greiner Bio-One at which time upon receipt, arrangements for product return to Greiner Bio-One will be made for replacement or credit. They were requested to provide a list of their customers to Greiner Bio-One that received the affected item. For additional information call Greiner Bio-One at (888) 266-3883.
Quantity in commerce: 142,400 pieces
Distribution: Nationwide Distribution including the states of CA, GA, IL, KS, MA, IL, PA and VA.
Product codes and lots: Item number: 450263D, Lot number A1008033

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)