Recall Z-0868-2021 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Laerdal Medical (Suzhou) Co., Ltd.
Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
| Date | Dec 18, 2020 |
| Status | Terminated |
| Reason | Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user. |
| Root cause | Device Design |
| Action | On December 18, 2020, the firm sent Urgent Medical Device Recall letters to affected customers. Customers were informed that the service life of the LCSU 4 may be reduced. Customers were asked to identify and secure affected units. Customers were told that they could continue to use their LCSU 4 unit until they receive a replacement unit, but were provided with safety measures: - Follow local protocols for back-up suction devices. Do not repeatedly block the patient tube for more than 10 seconds at a time at vacuum levels greater than 300 mmHg. - Only use canisters, tubes and accessories that |
| Quantity | 5035 |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120065 | PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES Plaxtron Industrial (M) Sdn. Bhd., Apr 3, 2012 |