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CLEARLITE, ANAESTHETIC FACE MASK,SIZE 5,LARGE ADULT,ORANGE SEAL,NO HOOK RING,22F

Intersurgical Incorporated · Model 7295001 · UDI-DI 05030267155194

BSJ Prescription
10
510(k) clearances
115
Adverse events
1
Recalls
161
Facilities

Description

CLEARLITE, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, ORANGE SEAL, NO HOOK RING, 22F

Recalls

DateFirmReason
2011-09-12Engineered Medical Systems,IncThe mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

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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.