Class II — King Systems Corp.
| Recalling firm | KING SYSTEMS |
|---|---|
| Registered facility | KING SYSTEMS CORPORATION. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector without Suction port. If the incorrect component is not identified prior to clinical use, the incorrect connector would be replaced during the case without risk to the patient and could result in a short delay of the procedure. |
| Product | Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desi… |
| Quantity | 900 units |
| Distribution | US Nationwide in the states of IL, IN, KY, MI, PA, and TN |
| Initiated | 2015-02-17 |
| Classified | 2015-04-01 |
| Terminated | 2015-10-27 |
| Recall number | Z-1361-2015 |
| 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 II recall — King Systems Corp. (Z-1361-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70610/
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