FDA Device recall 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…
- FDA Device
- Class I
- terminated
- Published 2013-10-09
On 2013-10-09 the FDA classified a Class I recall of Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical… by King Systems, citing 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 bre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2272-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-08-23 |
| Published | 2013-10-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | King Systems |
| Distribution | US |
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.
Identifiers
| code_info | Part Number DF4110-61 Lot Number I063N |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2272-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.