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Devices
Device Recall LCSU 4
Model / Serial
Affected units are labelled with Manufacturing Dates in the range 20150501 to 20161028.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
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)
Manufacturer
Laerdal Medical Corporation
1 Event
Recall of Device Recall LCSU 4
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Manufacturer
Laerdal Medical Corporation
Manufacturer Address
Laerdal Medical Corporation, PO Box 1840, 167 Myers Corners Rd, Wappingers Falls NY 12590-3869
Manufacturer Parent Company (2017)
Laerdal Medical Corporation
Source
USFDA
Language
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