Anesthesia Circuit Kit Flex (P)2 recalled for potential breathing hose cracks
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex (P)2 due to the potential for cracks to form in the breathing circuit hose. This FDA Class I recall affects approximately 9,250 units distributed domestically and internationally.
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: This FDA Class I recall sets a minimum severity threshold of Severe per regulatory guidelines. The potential for cracks in the breathing circuit hose could compromise the anesthetic delivery system, though no injuries or deaths have been reported.
Plain-English summary
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex (P)2 (Model MP02752), an accessory used to conduct medical gases between an anesthesia machine and a patient during anesthetic procedures. The kit is designed for single use only.
The FDA has classified this as a Class I recall due to the potential for cracks to form in the breathing circuit hose. Such cracks could compromise the integrity of the anesthetic delivery system during use.
Approximately 9,250 units have been distributed domestically nationwide and internationally to 23 countries including Austria, Belgium, China, France, Germany, India, Italy, Japan, and others. The affected kits are identified by Model/Catalog Number MP02752 and UDI Number 04048675389729, with all lot numbers affected.
The recalled product
- Product
- Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is…
- Manufacturer
- Draeger, Inc.
- Affected units
- 9,250
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 (3)
- Model/Catalog Number: MP02752
- UDI Number 04048675389729
- All lot numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Draeger, 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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