Reported Apr 26, 2017 · Terminated

Laerdal Compact Suction Unit ¿ 4 under the following labels

Laerdal Medical Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Laerdal Medical Corporation · PO Box 1840 · Wappingers Falls, NY · 12590-3869

Is this the product you have?

Laerdal Compact Suction Unit ¿ 4 under the following labels

3 of 3 products

Products covered by this recall
#Product as published
1300 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
288005101 - 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) &
3800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)
Lot codes and dates
  • Affected units are labelled with Manufacturing Dates in the range 20150501 to 20161028.
Amount recalled
4,377 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 25, 2018 · Data as of Sep 19, 5:36 PM UTC

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