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BREATHING BAG

King Systems Corporation · Model 5137 · UDI-DI 00612649180304

BTC Prescription

510(k) clearances

171

Adverse events (5 deaths)

Recalls

Facilities

Description

BREATHING BAG,1/2L,NEOPRENE

Recalls

Date	Firm	Reason
2023-04-17	Draeger Medical, Inc.	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
2023-04-17	Draeger Medical, Inc.	Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
2018-03-15	Teleflex Medical Europe Ltd	These 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
2007-12-07	Medline Industries Inc	Separation from Bushing: The breathing bag may separate from the bushing during use.
2007-12-07	Medline Industries Inc	Separation from Bushing: The breathing bag may separate from the bushing during use.
2007-12-07	Medline Industries Inc	Separation from Bushing: The breathing bag may separate from the bushing during use.
2007-12-05	Ventlab Corporation	During 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.