CLASS II Device recall · Reported 27 Jan 2021 · FDA Enforcement Report
Laerdal Compact Suction Unit (LCSU recalled
Laerdal Medical (Suzhou) Co is recalling Laerdal Compact Suction Unit (LCSU, distributed nationwide in the US. The recall was initiated on 18 Dec 2020 and the FDA has classified it as Class II.
Check your package
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-0868-2021
- FDA event ID
- 86702
- Recalling firm
- Laerdal Medical (Suzhou) Co, Suzhou, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2020
- FDA classified
- 15 Jan 2021
- Reported
- 27 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 18 Dec 2020 | Recall initiated by company | |
| 15 Jan 2021 | Classified by FDA | +28 days |
| 27 Jan 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution.
Questions about this recall
Is Laerdal Compact Suction Unit (LCSU recalled?
Yes. Laerdal Medical (Suzhou) Co recalled Laerdal Compact Suction Unit (LCSU on 18 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0868-2021.
Why was it recalled?
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.
Which lots are affected?
Serial number range 1808090001 to 2006060045
Where was it sold?
Worldwide distribution - US Nationwide distribution.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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