Recall Z-1873-2017— Laerdal Medical Corporation

Class II FDA medical device recall by Laerdal Medical Corporation, initiated 2017-01-08, terminated 2018-05-25. FDA's recall record names no specific 510(k) clearance for this event. 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). Reason: The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged..

Recalling firm

Laerdal Medical Corporation

Classification

Class II

Status

Terminated

Initiated

2017-01-08

Terminated

2018-05-25

Firm location

Wappingers Falls, NY, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.