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ID Bag Set (N) 110

Drägerwerk AG & Co. KGaA · Model MP01329 · UDI-DI 04048675249016

BTC
10
510(k) clearances
171
Adverse events (5 deaths)
7
Recalls
99
Facilities

Recalls

DateFirmReason
2023-04-17Draeger Medical, Inc.Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
2023-04-17Draeger Medical, Inc.Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
2018-03-15Teleflex Medical Europe LtdThese products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause All
2007-12-07Medline Industries IncSeparation from Bushing: The breathing bag may separate from the bushing during use.
2007-12-07Medline Industries IncSeparation from Bushing: The breathing bag may separate from the bushing during use.
2007-12-07Medline Industries IncSeparation from Bushing: The breathing bag may separate from the bushing during use.
2007-12-05Ventlab CorporationDuring setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.

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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.