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Cryostore
ORIGEN BIOMEDICAL, INC. · Model CS500N · UDI-DI 10816203020366
KSR
Prescription
10
510(k) clearances
617
Adverse events (8 deaths)
4
Recalls
32
Facilities
Description
CryoStore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-01-20 | DeRoyal Industries Inc | Device's needle may become dislodged from the cup during shipment or during use. |
| 2012-01-20 | DeRoyal Industries Inc | Device's needle may become dislodged from the cup during shipment or during use. |
| 2006-06-21 | Becton Dickinson & Company | Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection. |
| 2005-12-01 | Becton Dickinson & Company | Cracked finger grip luer adapter components on the Push Button Blood Collection Set. |
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