Draeger Medical Recalls VentStar Basic 180 Breathing Circuits
Draeger Medical is recalling 325 units of VentStar Basic 180 breathing circuits due to incorrect pre-assembly that may cause incorrect connections.
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 poses a risk of harm through incorrect connection, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Draeger Medical, Inc. is recalling 325 units of VentStar Basic 180 breathing circuits, catalog number MP00349. 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, creating a potential for incorrect connection or short circuiting of the circuit. This defect could compromise the safe delivery of respiratory gases to the patient.
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 have these specific breathing circuits should stop using them immediately and contact Draeger Medical for further instructions.
The recalled product
- Product
- VentStar Basic 180, Catalog Number MP00349 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 Sets wit
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 325
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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