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Cryostore
ORIGEN BIOMEDICAL, INC. · Model CS500i2 · UDI-DI 10816203021189
KSR
Prescription
10
510(k) clearances
615
Adverse events (8 deaths)
4
Recalls
32
Facilities
Description
Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 12
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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