Reported Oct 14, 2020 · Terminated
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are…
Ab Ulax
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AB ULAX · Merkuriusgatan 8 · Motala, N/A · N/A
Is this the product you have?
- 1500 Flex Heat and Moisture Exchanger
- Catalog Reference 150 - Product UsageHeat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia
- Lot codes and dates
- SAP 109381602
- Lots15 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
2018-09-252018-11-202018-12-102018-12-202019-01-032019-02-202019-03-202019-04-152019-05-302019-06-252019-08-
- Amount recalled
- 1,484,100 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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