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U.S. Department of Health and Human Services

Class 2 Device Recall Laerdal Compact Suction Unit, LCSU 4

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 Class 2 Device Recall Laerdal Compact Suction Unit, LCSU 4see related information
Date Initiated by FirmDecember 18, 2020
Create DateJanuary 15, 2021
Recall Status1 Terminated 3 on December 11, 2023
Recall NumberZ-0868-2021
Recall Event ID 86702
510(K)NumberK120065 
Product Classification Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
ProductLaerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
Code Information Serial number range 1808090001 to 2006060045 
FEI Number 3004993040
Recalling Firm/
Manufacturer		 Laerdal Medical (Suzhou) Co., Ltd.
Science & Technology Ind. Park
No. 19 Bldg., Huoju Road
Suzhou China
For Additional Information ContactLaerdal Sales Office
877-5237325 Ext. 3234
Manufacturer Reason
for Recall		Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user.
FDA Determined
Cause 2		Device Design
ActionOn December 18, 2020, the firm sent Urgent Medical Device Recall letters to affected customers. Customers were informed that the service life of the LCSU 4 may be reduced. Customers were asked to identify and secure affected units. Customers were told that they could continue to use their LCSU 4 unit until they receive a replacement unit, but were provided with safety measures: - Follow local protocols for back-up suction devices. Do not repeatedly block the patient tube for more than 10 seconds at a time at vacuum levels greater than 300 mmHg. - Only use canisters, tubes and accessories that are approved for the device by Laerdal Medical. - When adjusting the vacuum level: When the desired vacuum level is reached; unblock the patient tube immediately. - During patient treatment do not occlude or block the patient tube by intentional bending or squeezing. The patient tube should only be temporarily occluded by suctioning matter. - When performing the Device Test: When the vacuum reaches minimum 500 mmHg immediately release the blocking. - If your affected LCSU 4 experiences a loss of peak suction, please report this to your local Laerdal Sales office, for US: 877-LAERDAL (523-7325), customerservice@laerdal.com or, for Canada: (416) 298-9600, savelives@laerdal.com Customers must complete the included reply form to acknowledge receipt of the recall notice and to identify any units needing replacement, and return the information to Stericycle.
Quantity in Commerce5035
DistributionWorldwide distribution - US Nationwide distribution.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JCX
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