Double Swivel Connector with Suction Port Connector — Class II medical device recall Z-1361-2015
Terminated recall by King Systems Corp., reported 2015-04-08, distributed nationwide. Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector wit
| Recall number | Z-1361-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | King Systems Corp., Noblesville, IN, United States |
| Recall initiated | 2015-02-17 |
| Classified | 2015-04-01 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2015-10-27 |
| Distributed | Nationwide (US) |
| Quantity | 900 units |
| Reason classes | labeling |
| Lot numbers | 1737171 |
| Model numbers | 7169 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1361-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.