Reported Apr 8, 2015 · Terminated
Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway…
King Systems Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: King Systems Corp. · 15011 Herriman Blvd · Noblesville, IN · 46060-4253
Is this the product you have?
- Double Swivel Connector with Suction Port Connector, Airway (Extension)
- King Systems part 7169 Product UsageAn 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 desired
- Lot codes and dates
- Part number 7169 Lot number 1737171
- Amount recalled
- 900 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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