Home › Fresenius Kabi AG › PLASMALINK Bottle, 1000 mL with Locking Luer Adapter
PLASMALINK Bottle, 1000 mL with Locking Luer Adapter
Fresenius Kabi AG · Model 6R2069 · UDI-DI 04086000100342
KSR
Prescription
10
510(k) clearances
615
Adverse events (8 deaths)
4
Recalls
32
Facilities
Description
For the collection, storage, and shipment of plasma prior to fractionation. Sterile Fluid Path.
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.