Recall Z-0973-2018 ยท JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Laerdal Medical Corporation
LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for trachea
| Date | Aug 31, 2017 |
| Status | Terminated |
| Reason | A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms. |
| Root cause | No Marketing Application |
| Action | On September 5, 2017, a letter was mailed to customers notifying them that they received one of the units subject to recall. The letter requested that the customer return the affected item for a replacement. Questions or concerns can be directed to 1-877-523-7325 or email: customerservice@laerdal.com , referencing the following number: 2017-R-05. |
| Quantity | 204 |
| Distribution | Nationally |
| 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 |