Class I — King Systems Corp.
| Recalling firm | KING SYSTEMS |
|---|---|
| Registered facility | KING SYSTEMS CORPORATION. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| 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-piece. |
| Quantity | 1 case; 40 units |
| Distribution | Nationwide Distribution - NE only. |
| Initiated | 2012-08-23 |
| Classified | 2013-09-27 |
| Terminated | 2013-11-18 |
| Recall number | Z-2272-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — King Systems Corp. (Z-2272-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66184/
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