Z-1873-2017 Class II Terminated

Recalled by Laerdal Medical Corporation — Wappingers Falls, NY

Recall Details

Product Type
Devices
Report Date
April 26, 2017
Initiation Date
January 8, 2017
Termination Date
May 25, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,377 units

Product Description

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 for Recall

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

Distribution Pattern

Nationwide

Code Information

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