VACUETTE SAFELINK, REF: 450210
FDA device recall Z-0802-2025 · posted 2025-01-03 · Open, Classified
Recall details
- Recalling firm
- Greiner Bio-One GmbH
- 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.
- Action taken
- 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 recalls.us@gbo.com If you have additional questions, contact the firm's Technical Service Department at 800-515-8112.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FMI
- Quantity affected
- 188,800 pcs
- Distribution
- US Nationwide distribution in the states of IL, PA.
- Date initiated
- 2024-11-19
- Date posted
- 2025-01-03
- Location
- Kremsmunster, Austria
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACUETTE SAFELINK Holder with male luer lock (K180545) | Greiner Bio-One Na, Inc. | 2018-05-21 |