HOLDEX Single-Use Holder PP closed pack recallZ-2957-2011 · Greiner Bio-One North America, Inc. · initiated Jun 29, 2011
Terminated All recalls posted in August 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Greiner Bio-One North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-2957-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 29, 2011
- Posted by the FDA
- Aug 8, 2011
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 142,400 pieces
- Product code
- FMI
- FDA submissions
- K980768
- Distribution
- Nationwide Distribution including the states of CA, GA, IL, KS, MA, IL, PA and VA.
Product description
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.
Code information (models, lots, serial numbers)
Item number: 450263D, Lot number A1008033
Other devices under the same FDA submission
1 device cleared under K980768 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vacuette 450263DGreiner Bio-One GmbH · Needle, hypodermic, single lumen1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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