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Getinge Assured Steam Sterilization Indicator

STERITEC PRODUCT MFG. CO., INC. · Model 61301606814 · UDI-DI 00814434021209

LRT
5
510(k) clearances
10
Adverse events
1
Recalls
2
Facilities

Recalls

DateFirmReason
2012-08-02Steris CorporationOn 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.