Draeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 75 units of VentStar Basic (P) 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuit.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class I. According to the severity rubric, FDA Class I recalls are assigned a score of 4 (Severe) or higher, as they represent a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Draeger Medical, Inc. is recalling 75 units of VentStar Basic (P) 250 breathing circuits, Catalog Number MP00352. These devices are intended for single use to conduct respiratory gases between an anesthesia machine or ventilator and a patient. The recall is classified as Class I by the FDA.
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 units should stop using them immediately. They should contact Draeger Medical, Inc. for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- VentStar Basic (P) 250, Catalog Number MP00352 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
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 75
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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