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Shield refill, Careshield

J.H. Orsing AB · Model Careshield · UDI-DI 07393507592011

EHZ Prescription
10
510(k) clearances
9
Adverse events
1
Recalls
141
Facilities

Description

Careshield

Recalls

DateFirmReason
2022-11-02Stradis Medical, LLC dba Stradis HealthcareMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in

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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.