Universal Flex2 Breathing Circuit Class I 510(k) Exempt recall
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…
Why was Universal Flex2 Breathing Circuit Class I 510(k) Exempt 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number DF4110-61 Lot Number I063N
- 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…
- Recalling firm
- King Systems Corp.
- Quantity
- 1 case; 40 units
- Distribution
- Nationwide Distribution - NE only.
- Recall date
- October 9, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)