FDAFDA · Food and drugs·Recall number 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.
Published October 9, 2013 · Recall initiated: August 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- King Systems Corp.
- Distributor
- Nationwide Distribution - NE only.
- Lot
- Part Number DF4110-61 Lot Number I063N
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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