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GALEMED CORPORATION · Model 7WHP61 · UDI-DI 04710810119552

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

Description

CS Water Trap Kit, Y Type, 15M

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.