Z-2272-2013 Class I Terminated
FDA device recall Z-2272-2013 was initiated by King Systems Corp. on August 23, 2012 and is designated Class I. 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 … The recall status is terminated (terminated November 18, 2013). Affected quantity: 1 case; 40 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2013
- Initiation Date
- August 23, 2012
- Termination Date
- November 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 case; 40 units
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.
Distribution Pattern
Nationwide Distribution - NE only.
Code Information
Part Number DF4110-61 Lot Number I063N