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Infinity ID WaterLock2

Drägerwerk AG & Co. KGaA · Model 6872020 · UDI-DI 04048675249351

BYH
10
510(k) clearances
39
Adverse events (3 deaths)
2
Recalls
63
Facilities

Recalls

DateFirmReason
2004-07-12Medex IncThe non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
2004-07-12Medex IncThe non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.

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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.