Device 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.
Z-2272-2013
Product summary
- Event
- Event 66184
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1 case; 40 units
- Official record key
device-enforcement:Z-2272-2013
Official wording
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.
Code information: Part Number DF4110-61 Lot Number I063N
Distribution pattern: Nationwide Distribution - NE only.
Derived failure modes
-
Unknown
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.