The Recall Desk
SevereFDA (Devices)·Z-0868-2021·Announced 2021-01-27

Laerdal Compact Suction Unit Recalled for Potential Suction Loss

Laerdal Medical is recalling 5,035 Compact Suction Units (LCSU 4) because component failures may cause the device to lose suction, potentially delaying treatment or causing suffocation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of suffocation, which constitutes a significant injury risk under the severity rubric.

Plain-English summary

Laerdal Medical (Suzhou) Co., Ltd. is recalling 5,035 units of the Laerdal Compact Suction Unit (LCSU 4). The affected catalog numbers are 880051, 880061, 881151, 880052, 880062, and 881152. The devices have serial numbers ranging from 1808090001 to 2006060045. The units were distributed worldwide and nationwide in the United States.

The recall was initiated because component failures may cause the unit to lose all suction. If the device fails, users will need to obtain alternate suction devices or methods. This can lead to a delay in treatment and, in the worst-case scenario, potential suffocation if an alternative suction or ventilation method is not administered by the user.

The Laerdal Compact Suction Unit is intended for intermittent operation to remove secretions, blood, or vomit from a patient's airway to allow ventilation. Users should check their device serial numbers against the affected range and contact the manufacturer for instructions on replacement or repair.

The recalled product

Product
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.
Manufacturer
Laerdal Medical (Suzhou) Co., Ltd.
Category
Medical Device — Suction Equipment
Hazard
Affected units
5,035

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial number range 1808090001 to 2006060045

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · suffocation

See all →