Recall Z-2272-2013— King Systems Corp.
Class I · Terminated
Class I FDA medical device recall by King Systems Corp., initiated 2012-08-23, terminated 2013-11-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- King Systems Corp.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-08-23
- Terminated
- 2013-11-18
- Firm location
- Noblesville, IN, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.