King Systems Double Swivel Connector Recalled for Mislabeling
King Systems Corp. is recalling 900 units of Double Swivel Connectors mislabeled as having a suction port. The error may cause a short procedure delay but poses no risk to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Moderate because it involves a minor labeling error where the source explicitly states there is no risk to the patient, only a potential short delay in procedure.
Plain-English summary
King Systems Corp. is recalling 900 units of Double Swivel Connectors with Suction Port, part number 7169, lot number 1737171. The product is mislabeled; the units are actually Double Swivel Connectors without a suction port. These airway connectors are intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask.
The recall was initiated because the incorrect labeling could lead to the use of the wrong component during a clinical procedure. If the incorrect component is not identified prior to clinical use, it would be replaced during the case. The source states that this replacement would occur without risk to the patient, though it could result in a short delay of the procedure.
The affected units were distributed nationwide in the states of Illinois, Indiana, Kentucky, Michigan, Pennsylvania, and Tennessee. Healthcare facilities and consumers should check their inventory for part number 7169, lot number 1737171, and contact King Systems Corp. for instructions on returning the product.
The recalled product
- 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…
- Manufacturer
- King Systems Corp.
- Hazard
- Affected units
- 900
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 7169 Lot number 1737171
Distribution
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