King Systems Universal Flex2 Breathing Circuit Recalled for Latex Mislabeling
King Systems Corp. is recalling Universal Flex2 Breathing Circuits that contain latex bags but are labeled as non-latex.
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 allergen mislabeling (latex) on a medical device, which fits the rubric criteria for 'High' severity (allergen mislabeling on common allergens).
Plain-English summary
King Systems Corp. is recalling Universal Flex2 Breathing Circuits, which are Class I, 510(k) exempt medical devices intended to administer medical gases to patients during anesthesia. The recall involves one case containing 40 units of the product.
The recall was initiated after a customer complaint indicated that the company received a breathing circuit with a latex breathing bag, despite the product being labeled as non-latex. The affected units are identified by Part Number DF4110-61 and Lot Number I063N.
The product was distributed nationwide, specifically to the Northeast region. Consumers and healthcare providers should check their inventory for this specific part and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-p
- Manufacturer
- King Systems Corp.
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)
- Part Number DF4110-61 Lot Number I063N
Distribution
Distributed nationwide across the United States.
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