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Recall Observatory FDA recall evidence

Device 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, 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)

Z-1873-2017

January 08, 2017

Class II

Product summary

Firm
Laerdal Medical Corporation
Event
Event 76744
Status
Terminated
Classification
Class II
Quantity
4,377 units
Official record key
device-enforcement:Z-1873-2017

Official wording

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

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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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