Vacuette, Safety Blood Collection Set with Luer Adapter recallZ-0797-03 · Greiner VACUETTE North America · initiated Mar 10, 2003
Terminated All recalls posted in May 2003
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 VACUETTE North America 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
The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.
FDA root cause category: Other
What the company is doing
Consignees were notified via certified letter on/about 3/6/2003 and were advised to stop distributing the product immediately and to discard any remaining product in stock.
Recall details
- Recall number
- Z-0797-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 10, 2003
- Posted by the FDA
- May 9, 2003
- Recalling firm
- Greiner VACUETTE North America
- Quantity
- 139000 units
- Product code
- JKA
- FDA submissions
- K011786
- Distribution
- Product was distributed to medical facilities Nationwide.
Product description
Vacuette, Safety Blood Collection Set with Luer Adapter
Code information (models, lots, serial numbers)
Item no. 450096, Lot #''s 02I09C, 02I11C and 02I20C
Other devices under the same FDA submission
5 devices cleared under K011786 — 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 450082Greiner Bio-One GmbH · Needle, hypodermic, single lumen3 reports
- Vacuette 450096Greiner Bio-One GmbH · Needle, hypodermic, single lumen3 reports
- Vacuette 450161Greiner Bio-One GmbH · Needle, hypodermic, single lumen2 reports
- Vacuette 450086Greiner Bio-One GmbH · Needle, hypodermic, single lumen1 report
- Vacuette 450095Greiner 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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