Home › Intersurgical Incorporated › QUADRALITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, NO HOOK RING, 15M
QUADRALITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, NO HOOK RING, 15M
Intersurgical Incorporated · Model 7191000 · UDI-DI 05030267079032
BSJ
Prescription
10
510(k) clearances
128
Adverse events
1
Recalls
161
Facilities
Description
QUADRALITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, NO HOOK RING, 15M (REPLACES TRADITIONAL MASK SIZE 0-1)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-09-12 | Engineered Medical Systems,Inc | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. |
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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.