Z-1873-2017Class II

Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG...

Name: Z-1873-2017 Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG...
Creator: Laerdal Medical Corporation
Published: 2017-01-08
License: https://open.fda.gov/license/

Laerdal Medical a/S / initiated 2017-01-08 / Terminated / root cause: manufacturing process

FDA source

Laerdal Medical Corporation began a recall of Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US)... on 2017-01-08. FDA classified it as Class II and gives the reason as "The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1873-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-08
Posted: 2017-04-20
Terminated: 2018-05-25
Recalling firm: Laerdal Medical a/S
Product: Laerdal Compact Suction Unit 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Reason for recall: The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On January 8, 2017 Laerdal Medical distributed Urgent Device Recall Notification Letters to their customers thru Stericycle. The documents were dispatched via standard UPS ground delivery. Laerdal Medical has discovered that the LCSU4 may turn on by itself when connected to a power source and/or may not be able to be turned off with the on/off button without removing the battery or external power source. You can continue to use your suction units until your replacement arrives by following the steps: Exception: Some LCSU 4 units have a RW label on the bottom. These units have been reworked by Laerdal Medical and are not affected by this Field Safety Notice, even if they have manufacturing dates within the 20150501 to 20161028 range. **Check On/Off functionality** You can run a quick test to identify if the unit has failing On/Off functionality: Turn unit on; Turn unit off again. If the unit cannot be turned off using the On/Off button, the unit contains a damaged component. The device should be taken out of service. The safety and effectiveness of the device is not affected by the failure of the On/Off button as long as it has power. Note that even if the unit passes this test, the problem may occur later. The actions below must be taken to ensure continued safe use of the LCSU 4 until you receive a replacement unit. **Actions to be taken to ensure continued safe use of the LCSU 4 until you receive a replacement unit** You can continue to use your LCSU 4 unit until you receive a replacement unit, but it is recommended to implement the following extra safety measures: Store the LCSU 4 unit without the battery connected so that it cannot turn on by itself. Perform routine checks of the On/Off functionality by turning the unit on and off using the On/Off button. All units with failing On/Off functionality should be removed from service. ** Actions to be taken if the On/Off functionality fails during clinical use** If the On/Off functionality fai
Quantity in commerce: 4,377 units
Distribution: Nationwide
Product codes and lots: Affected units are labelled with Manufacturing Dates in the range 20150501 to 20161028.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1873-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1873-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-20

Product code JCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)