Z-0973-2018Class II

LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device...

Name: Z-0973-2018 LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device...
Creator: Laerdal Medical Corporation
Published: 2017-08-31
License: https://open.fda.gov/license/

Laerdal Medical a/S / initiated 2017-08-31 / Terminated

FDA source

Laerdal Medical Corporation began a recall of 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... on 2017-08-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0973-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-31
Posted: 2018-03-12
Terminated: 2018-06-13
Recalling firm: Laerdal Medical a/S
Product: 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 tracheal suctioning and the suctioning of children and infants.
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Reason for recall: 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.
FDA 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: [email protected] , referencing the following number: 2017-R-05.
Quantity in commerce: 204
Distribution: Nationally
Product codes and lots: Affected SNs between: 170401A0001 and 170401A0270

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0973-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0973-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-12

Product code JCX

K120065Class IIPlaxtron Suction Unit, Model 88Aa51/88aa61 SeriesPlaxtron Industrial (M) Sdn. Bhd. / cleared 2012-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)