Z-2272-2013Class I

Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is...

Name: Z-2272-2013 Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is...
Creator: King Systems Corp.
Published: 2012-08-23
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2012-08-23 / Terminated / root cause: labeling and UDI

FDA source

King Systems Corp. began a recall of 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... on 2012-08-23. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2272-2013
Classification: Class I
Status: Terminated
Initiated: 2012-08-23
Posted: 2013-09-27
Terminated: 2013-11-18
Recalling firm: King Systems Corporation.
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.
Product code: CAI Circuit, Breathing (W Connector, Adaptor, 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 1 case; 40 units
Distribution: Nationwide Distribution - NE only.
Product codes and lots: Part Number DF4110-61 Lot Number I063N

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2272-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2272-2013	Class I	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-27

Product code CAI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)