VACUETTE SAFELINK Blood Collection Holder May Leak Due to Defective Sleeve
Greiner Bio-One GmbH is recalling VACUETTE SAFELINK blood collection holders because the protective rubber sleeve may bunch up and fail to retract, causing potential blood leakage from the device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device with a mechanical defect that poses a risk of occupational blood exposure. No illnesses or injuries have been reported in the source material, meeting the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The VACUETTE SAFELINK Holder with male luer lock (REF 450210) is a blood collection device manufactured by Greiner Bio-One GmbH. Approximately 188,800 units have been distributed nationwide, primarily in Illinois and Pennsylvania. The affected lot is A240338Q with expiration date February 27, 2015.
The protective rubber sleeve on the holder may bunch up and not retract properly when the device is used. This mechanical defect can cause blood to leak from the device, potentially exposing healthcare workers and laboratory personnel to bloodborne pathogens.
Healthcare facilities and laboratories using these blood collection devices should stop using affected units immediately. Contact Greiner Bio-One GmbH for replacement devices or additional instructions. Secure and safely dispose of any affected devices according to your facility's biohazard waste protocols.
The recalled product
- Product
- VACUETTE SAFELINK, REF: 450210
- Manufacturer
- Greiner Bio-One GmbH
- Hazard
- blood-leakage
- occupational-exposure
- mechanical-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 19120049207487
- Lot: A240338Q
- Expiration Date: 270215
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27