Z-1361-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2015
- Initiation Date
- February 17, 2015
- Termination Date
- October 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900 units
Product Description
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 desired.
Reason for Recall
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.
Distribution Pattern
US Nationwide in the states of IL, IN, KY, MI, PA, and TN
Code Information
Part number 7169 Lot number 1737171