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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could lead to incorrect connection or short circuiting, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
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.
- 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
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.
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