—#121659

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.

FDA product code: CAI — Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Part Number DF4110-61 Lot Number I063N

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: King Systems Corp.
Address: 15011 Herriman Blvd, Noblesville, Indiana 46060-4253

Distribution

Distribution pattern: Nationwide Distribution - NE only.

Timeline

Recall initiated: 2012-08-23
Posted by FDA: 2013-09-27
Terminated: 2013-11-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121659. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.