Vacuette Safelink, Ref: 450210 recallZ-0802-2025 · Greiner Bio-One GmbH · initiated Nov 19, 2024
Open, Classified
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 GmbH 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 VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
FDA root cause category: Process control
What the company is doing
On 11/19/2024, customers and distributors were mailed and emailed recall notices asking them to do the following: 1) Stop using and isolate affected devices. 2) If the product has been further distributed or transferred to another location, notify those locations of the recall, and advise the name/location in the provided space on the attached Product Disposition Site Confirmation. 3) Complete and return the Product Disposition Site Confirmation form via email to [email protected] If you have additional questions, contact the firm's Technical Service Department at 800-515-8112.
Recall details
- Recall number
- Z-0802-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 19, 2024
- Posted by the FDA
- Jan 3, 2025
- Recalling firm
- Greiner Bio-One GmbH
- Quantity
- 188,800 pcs
- Product code
- FMI
- FDA submissions
- K180545
- Distribution
- US Nationwide distribution in the states of IL, PA.
Product description
VACUETTE SAFELINK, REF: 450210
Code information (models, lots, serial numbers)
UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vacuette 450210Greiner Bio-One GmbH · Needle, hypodermic, single lumen1 recall0 reports
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 16, 2026. Text above is shown as published by the FDA.
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