CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report
Double Swivel Connector with Suction Port Connector, Airway recalled
King Systems is recalling Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part, distributed nationwide in the US. The recall was initiated on 17 Feb 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1361-2015
- FDA event ID
- 70610
- Recalling firm
- King Systems, Noblesville, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2015
- FDA classified
- 1 Apr 2015
- Reported
- 8 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Masks, Gloves & PPE
Timeline
| 17 Feb 2015 | Recall initiated by company | |
| 1 Apr 2015 | Classified by FDA | +43 days |
| 8 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide in the states of IL, IN, KY, MI, PA, and TN
Nationwide IllinoisIndianaKentuckyMichiganPennsylvaniaTennessee
Questions about this recall
Is Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part recalled?
Yes. King Systems recalled Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part on 17 Feb 2015. The recall is Class II and its status is Terminated. Recall number Z-1361-2015.
Why was it 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.
Which lots are affected?
Part number 7169 Lot number 1737171
Where was it sold?
US Nationwide in the states of IL, IN, KY, MI, PA, and TN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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