Agency classClass IOur severity:Severe FDA (Devices)·Z-0740-2019·Announced 2019-01-30

Draeger Medical Recalls VentStar Watertrap Breathing Circuits Due to Assembly Error

Draeger Medical is recalling 25 units of VentStar Watertrap (P) 180 breathing circuits because they were incorrectly pre-assembled, posing a risk of incorrect connection.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit"

Plain-English summary

Draeger Medical, Inc. is recalling 25 units of VentStar Watertrap (P) 180 breathing circuits, Catalog Number MP00361. These devices are intended for single use to conduct respiratory gases between an anesthesia machine or ventilator and a patient. The recall covers all lots of the product.

The recall was initiated because the breathing circuits were incorrectly pre-assembled. This defect creates a potential for incorrect connection or a short circuit of the breathing circuit. The affected units were distributed in the United States to the states of Alabama, California, Colorado, Connecticut, Florida, Kentucky, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina, and Texas.

Healthcare facilities and consumers who possess these specific breathing circuits should stop using them immediately. They should contact Draeger Medical, Inc. for instructions on how to return or dispose of the affected units.

The recalled product

Product: VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia…
Manufacturer: Draeger Medical, Inc.
Category: Medical Device — Anesthesia Equipment
Hazard: incorrect-connection
short-circuit
Affected units: 25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Lots

Distribution

Distributed in 12 states:

Part of a larger recall action

This product is one of 9 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · Draeger Medical, Inc.

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