1500 Flex Heat and Moisture Exchanger recall
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of…
Why was 1500 Flex Heat and Moisture Exchanger recalled?
Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. If the HME separates, the ventilator circuit may not provide adequate ventilation to the patient, potentially resulting in lack of oxygen leading to hypoxia or death.
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?
SAP 109381602, Lots: 2018-09-25 2018-11-20 2018-12-10 2018-12-20 2019-01-03 2019-02-20 2019-03-20 2019-04-15 2019-05-30 2019-06-25 2019-08- 15 2019-09-05 2019- 11-05 2019-11-25 *** SAP 109381603, Lots 2019-12-20 2020-04-30 2020-05-15 2020-05-20 2020-06-15 2020-06-30
- Product
- 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of…
- Recalling firm
- AB ULAX
- Quantity
- 1,484,100 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Sweden, Taiwan, Hong Kong, and Spain.
- Recall date
- October 14, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)