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Open, Classified

VACUETTE SAFELINK, REF: 450210

FDA Recall Z-0802-2025 · Posted 2025-01-03

Recalling FirmGreiner Bio-One GmbH
Recall StatusOpen, Classified
Product CodeFMI
Date Initiated2024-11-19
Product Quantity188,800 pcs

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of IL, PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180545VACUETTE SAFELINK Holder with male luer lockGreiner Bio-One Na, Inc. · 2018-05-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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