Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single… recallZ-2134-2008 · Greiner Bio-One North America, Inc. · initiated May 16, 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: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2134-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 16, 2008
- Posted by the FDA
- Sep 11, 2008
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 1,606,005 units
- Product code
- FMI
- FDA submissions
- K980768
- Distribution
- Class II Recall - Nationwide Distribution.
Product description
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.
Code information (models, lots, serial numbers)
Item #450216, Lot #A10074, A100745, A100746, A100747, A110749, and A110750.
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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