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.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex."
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…
- 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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