Z-0802-2025Class II

Vacuette Safelink, Ref: 450210

Name: Z-0802-2025 Vacuette Safelink, Ref: 450210
Creator: Greiner Bio-One GmbH
Published: 2024-11-19
License: https://open.fda.gov/license/

Greiner Bio-One GmbH / initiated 2024-11-19 / Open, Classified / root cause: manufacturing process

FDA source

Greiner Bio-One GmbH began a recall of VACUETTE SAFELINK, REF: 450210 on 2024-11-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0802-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-19
Posted: 2025-01-03
Recalling firm: Greiner Bio-One GmbH
Product: Vacuette Safelink, Ref: 450210
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 188,800 pcs
Distribution: US Nationwide distribution in the states of IL, PA.
Product codes and lots: UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0802-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0802-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-03

Product code FMI

K180545Class IIVACUETTE SAFELINK Holder with male luer lockGreiner Bio-One Na, Inc. / cleared 2018-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)