CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report

Laerdal Compact Suction Unit ¿ 4 under the following recalled

Laerdal Medical is recalling Laerdal Compact Suction Unit ¿ 4 under the following labels: canister, distributed nationwide in the US. The recall was initiated on 8 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAffected units are labelled with Manufacturing Dates in the range 20150501 to 20161028.
Quantity recalled4,377 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1873-2017
FDA event ID
76744
Recalling firm
Laerdal Medical, Wappingers Falls, NY
Classification
Class II
Status
Terminated
Recall initiated
8 Jan 2017
FDA classified
20 Apr 2017
Reported
26 Apr 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

8 Jan 2017Recall initiated by company
20 Apr 2017Classified by FDA+102 days
26 Apr 2017Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.

Product as listed by the FDA

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)

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Why was it recalled?

The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.

Which lots are affected?

Affected units are labelled with Manufacturing Dates in the range 20150501 to 20161028.

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Laerdal Medical

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DeviceCLASS IILaerdal Compact Suction Unit 4 RTCA recalled by Laerdal MedicalLaerdal MedicalOtherNationwide
DeviceCLASS IILcsu 4, Laerdal Compact Suction Unit The Lcsu recalledLaerdal MedicalOtherNationwide

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