Anesthesia Circuit Kit Flex 6 Recalled for Potential Breathing Hose Cracks
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex 6 (Model MP02744) due to potential cracks forming in the breathing circuit hose. Approximately 293,660 units were distributed nationwide 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: FDA Class I classification for a critical anesthesia breathing circuit component with potential for structural failure. Per the rubric, FDA Class I recalls have a minimum score of 4; the score remains 4 (Severe) rather than 5 (Critical) because no deaths or reported serious injuries are mentioned in the source.
Plain-English summary
Draeger, Inc. is recalling the Anesthesia Circuit Kit Flex 6, Model MP02744. This is a medical accessory used to conduct anesthetic medical gases between an anesthesia machine and a patient during medical procedures. The kit is intended for single use only.
The FDA has classified this recall as Class I due to the potential for cracks to form in the breathing circuit hose. A compromised breathing circuit hose could affect the safe delivery of anesthesia and pose a risk to patient safety.
Approximately 293,660 units have been distributed. Within the United States, distribution was nationwide. Internationally, the product was distributed to Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, France, Germany, Ghana, Greece, Guatemala, Hungary, India, Italy, Japan, Panama, Philippines, Portugal, Singapore, South Africa, Spain, Sweden, and the United Kingdom. The affected product can be identified by Model/Catalog Number MP02744 and includes all lot numbers.
Healthcare providers and facilities should immediately examine anesthesia circuit kits for any signs of cracking or damage. Units showing damage should be removed from service and not used. Contact Draeger, Inc. for additional information regarding this recall.
The recalled product
- Product
- Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 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
- 293,660
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: MP02744
- UDI Number 040486775389675
- 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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