Anesthesia Circuit Kit Flex 2 recalled due to breathing hose crack risk
Draeger's Anesthesia Circuit Kit Flex 2 is recalled because of the potential for cracks to form in the breathing circuit hose. No injuries have been reported.
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 medical device recall with potential for cracks in critical anesthesia delivery equipment. Per the rubric, FDA Class I recalls never score below 4. While no illnesses or injuries have been reported, the potential hazard to anesthesia delivery integrity during patient care justifies a Severe rating.
Plain-English summary
Draeger, Inc. has recalled the Anesthesia Circuit Kit Flex 2 (Model MP02738) due to the potential for cracks forming in the breathing circuit hose. This accessory conducts medical gases between an anesthesia machine and a patient during anesthesia.
The potential for hose cracks poses a risk during use, as integrity of the breathing circuit is critical for proper anesthesia gas delivery. No illnesses or injuries have been reported.
The recall affects 780 units with distribution throughout the United States and internationally. All lot numbers of this model are included in the recall.
The recalled product
- Product
- Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 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
- 780
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: MP02738
- UDI Number 04048675389637
- 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.
See all 7 products in this recall →Related recalls
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