Plastic Cannula Holdex Tube Holder, Item number: 450216.… recallZ-2198-2008 · Greiner Bio-One North America, Inc. · initiated Aug 5, 2008
Terminated All recalls posted in September 2008
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 become stuck in the tube stopper with the blunt end of the needle facing out.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-2198-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 5, 2008
- Posted by the FDA
- Sep 30, 2008
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 150,000 pcs
- Product code
- FMI
- FDA submissions
- K980768
- Distribution
- AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV.
Product description
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.
Code information (models, lots, serial numbers)
Lot#: A030804
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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