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.
FDA Recall Z-2272-2013 · Posted 2013-09-27
Recalling FirmKing Systems Corp.
Recall StatusTerminated
Product CodeCAI
Date Initiated2012-08-23
Date Terminated2013-11-18
Product Quantity1 case; 40 units
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.
Firm Action
Ambu, Inc. sent a letter dated June 24, 2013, informing the customer that they have decided to discontinue the manufacture and sales of the King Systems latex breathing bags and to conver all customers to their King Systems latex-free breathing bags. The customer was advised to adjust their inventories accordingly and transition to the latex free part number as their inventory levels reach their minimums. For questions the customer was advised to call 317-403-8677.
For questions regarding this recall call 317-776-6823.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution - NE only.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.