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

FDA device recall Z-2272-2013 · posted 2013-09-27 · Terminated

Recall details

Recalling firm

King Systems Corp.

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.

Action taken

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

Status

Terminated

Product code

CAI

Quantity affected

1 case; 40 units

Distribution

Nationwide Distribution - NE only.

Date initiated

2012-08-23

Date posted

2013-09-27

Date terminated

2013-11-18

Location

Noblesville, IN