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MacoSeal PS2-AS

MACO PHARMA · Model PS2-AS · UDI-DI 03567050071970

KSD Prescription
1
510(k) clearances
10
Adverse events (1 deaths)
1
Recalls
18
Facilities

Description

The MacoSeal PS2-AS is a portable and fully automatic system for sealing PVC tubes, especially tubes in blood pack systems. It performs pre-cut welding on wet or dry tube using high frequency. The MacoSeal PS2-AS can be used either in fixed collection or in mobile collection or preparation site.

Recalls

DateFirmReason
2011-01-31Haemonetics CorporationBattery pack may have exposed wire becoming hot

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Data 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.