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U.S. Department of Health and Human Services

Class 2 Device Recall LCSU 4

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  Class 2 Device Recall LCSU 4 see related information
Date Initiated by Firm January 08, 2017
Create Date April 20, 2017
Recall Status1 Open3, Classified
Recall Number Z-1873-2017
Recall Event ID 76744
Product Classification Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
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)
Code Information Affected units are labelled with Manufacturing Dates in the range 20150501 to 20161028.
Recalling Firm/
Manufacturer
Laerdal Medical Corporation
PO Box 1840
167 Myers Corners Rd
Wappingers Falls NY 12590-3869
For Additional Information Contact Stericycle
855-741-4991
Manufacturer Reason
for Recall
The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On January 8, 2017 Laerdal Medical distributed Urgent Device Recall Notification Letters to their customers thru Stericycle. The documents were dispatched via standard UPS ground delivery. Laerdal Medical has discovered that the LCSU4 may turn on by itself when connected to a power source and/or may not be able to be turned off with the on/off button without removing the battery or external power source. You can continue to use your suction units until your replacement arrives by following the steps: Exception: Some LCSU 4 units have a RW label on the bottom. These units have been reworked by Laerdal Medical and are not affected by this Field Safety Notice, even if they have manufacturing dates within the 20150501 to 20161028 range. **Check On/Off functionality** You can run a quick test to identify if the unit has failing On/Off functionality: Turn unit on; Turn unit off again. If the unit cannot be turned off using the On/Off button, the unit contains a damaged component. The device should be taken out of service. The safety and effectiveness of the device is not affected by the failure of the On/Off button as long as it has power. Note that even if the unit passes this test, the problem may occur later. The actions below must be taken to ensure continued safe use of the LCSU 4 until you receive a replacement unit. **Actions to be taken to ensure continued safe use of the LCSU 4 until you receive a replacement unit** You can continue to use your LCSU 4 unit until you receive a replacement unit, but it is recommended to implement the following extra safety measures: Store the LCSU 4 unit without the battery connected so that it cannot turn on by itself. Perform routine checks of the On/Off functionality by turning the unit on and off using the On/Off button. All units with failing On/Off functionality should be removed from service. ** Actions to be taken if the On/Off functionality fails during clinical use** If the On/Off functionality fai
Quantity in Commerce 4,377 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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