Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 8, 2015
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 suctio
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…
King Systems Corp. recalled Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems pa… — a moderate-severity action.
Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems pa… was recalled by King Systems Corp. in April 8, 2015. Reason: Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector wi…. Check the official notice for the remedy. Verify recall #Z-1361-2015 with the FDA Devices before acting.
The recall
King Systems Corp. issued this moderate-severity FDA Devices recall — Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector wi….
- Moderate
- severity level
- 900 units
- affected scope
- Class II
- classification
- April 8, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1361-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1361-2015) was formally reported on April 8, 2015, with the manufacturer initiating the action on February 17, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. King Systems Corp. is listed as the recalling firm, operating out of Noblesville, IN. Federal records list the affected scope as 900 units.
The documented reason for this recall is: 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 connecto… Distribution data in the federal record shows the product reached: US Nationwide in the states of IL, IN, KY, MI, PA, and TN. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
900 units
Related Recalls
6
6 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1361-2015 |
| Date reported | April 8, 2015 |
| Date initiated | February 17, 2015 |
| Recalling firm | King Systems Corp. |
| Firm location | Noblesville, IN |
| Affected scope | 900 units |
| Distribution | US Nationwide in the states of IL, IN, KY, MI, PA, and TN |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1361-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by King Systems Corp.. Units affected: 900 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2015. Severity: Moderate. Recall number: Z-1361-2015.
Where was the recalled product distributed? ▼
Distribution: US Nationwide in the states of IL, IN, KY, MI, PA, and TN.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1361-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 8, 2015.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.