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U.S. Department of Health and Human Services

Class 1 Device Recall Universal Flex2 Breathing Circuit

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  Class 1 Device Recall Universal Flex2 Breathing Circuit see related information
Date Initiated by Firm August 23, 2012
Date Posted September 27, 2013
Recall Status1 Terminated 3 on November 18, 2013
Recall Number Z-2272-2013
Recall Event ID 66184
Product Classification Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
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.
Code Information Part Number DF4110-61 Lot Number I063N
Recalling Firm/
Manufacturer		 King Systems Corp.
15011 Herriman Blvd
Noblesville IN 46060-4253
For Additional Information Contact
317-776-6823
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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