Z-1361-2015Class II

Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169

Name: Z-1361-2015 Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169
Creator: King Systems Corp.
Published: 2015-02-17
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2015-02-17 / Terminated / root cause: labeling and UDI

FDA source

King Systems Corp. began a recall of Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to... on 2015-02-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1361-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-17
Posted: 2015-04-01
Terminated: 2015-10-27
Recalling firm: King Systems Corporation.
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 desired.
Product code: BZA Connector, Airway (Extension)
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.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Kingsystems sent an Urgent Medical Device Recall letter dated February 17, 2015 to affected customers. The letter identified the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call your King Systems customer service representative at 800.642.5464.
Quantity in commerce: 900 units
Distribution: US Nationwide in the states of IL, IN, KY, MI, PA, and TN
Product codes and lots: Part number 7169 Lot number 1737171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1361-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1361-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-01

Product code BZA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)