Food, drugs, devices › King Systems Corp.
Device recall: Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to
King Systems Corp. (Noblesville, IN) initiated this device recall on 23 Aug 2012; FDA lists 1 product record under event 66184, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 5% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 18 Nov 2013. Initiation: voluntary: firm initiated. King Systems Corp. has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
King Systems Corp., Noblesville, IN.
Reason for recall
"King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex."
Distribution
"Nationwide Distribution - NE only."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2272-2013 | Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece. | 1 case; 40 units | Class I | Terminated | 9 Oct 2013 |
Context
Other enforcement events for King Systems Corp.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 17 Feb 2015 | Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway | Device | Class II | 1 |
| 13 Dec 2013 | King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part N | Device | Class II | 1 |
| 12 Dec 2013 | King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg | Device | Class II | 1 |
| 3 Sep 2013 | King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled | Device | Class III | 1 |
| 2 Nov 2012 | KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: | Device | Class II | 10 |
All 6 events for King Systems Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution - NE only."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Nov 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.