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Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems
HAEMONETICS CORPORATION · Model 00692-00 · UDI-DI 10812747011709
GKT
Prescription
10
510(k) clearances
6,589
Adverse events (267 deaths)
1
Recalls
39
Facilities
Description
PLS Bag w/NaCl Spike
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-25 | Fenwal Inc | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is |
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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.