The Recall Desk
HighFDA (Devices)·Z-1873-2017·Announced 2017-04-26

Laerdal Compact Suction Unit 4 Recalled for Electronic Component Damage

Laerdal Medical Corporation is recalling 4,377 Compact Suction Unit 4 devices because an electronic component may be damaged, potentially affecting the On/Off functionality.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (On/Off control) that poses a risk of harm if the device fails during use, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Laerdal Medical Corporation is recalling 4,377 units of the Laerdal Compact Suction Unit 4 (LCSU 4) nationwide. The recall affects both 300 ml and 800 ml canister versions, including complete units and replacement units, with manufacturing dates ranging from May 1, 2015, to October 28, 2016.

The recall was initiated because the On/Off functionality of the LCSU 4 is controlled by electronic components, one of which might be damaged. This defect could impact the device's ability to function correctly.

Consumers and healthcare facilities should stop using the affected units and contact Laerdal Medical Corporation for further instructions on repair or replacement.

The recalled product

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,
Affected units
4,377

Distribution

Distributed nationwide across the United States.

Same manufacturer · Laerdal Medical Corporation

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