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U.S. Department of Health and Human Services

Class 2 Device Recall APPARATUS, SUCTION, WARD USE, PORTABLE, ACPOWERED

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  Class 2 Device Recall APPARATUS, SUCTION, WARD USE, PORTABLE, ACPOWERED see related information
Date Initiated by Firm August 31, 2017
Create Date March 12, 2018
Recall Status1 Terminated 3 on June 13, 2018
Recall Number Z-0973-2018
Recall Event ID 79190
510(K)Number K120065  
Product Classification Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
Product LCSU 4, Laerdal Compact Suction Unit


The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.
Code Information Affected SNs between: 170401A0001 and 170401A0270
Recalling Firm/
Manufacturer		 Laerdal Medical Corporation
PO Box 1840
167 Myers Corners Rd
Wappingers Falls NY 12590-3869
For Additional Information Contact Don Garrison
845-297-7770
Manufacturer Reason
for Recall		 A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.
FDA Determined
Cause 2		 No Marketing Application
Action On September 5, 2017, a letter was mailed to customers notifying them that they received one of the units subject to recall. The letter requested that the customer return the affected item for a replacement. Questions or concerns can be directed to 1-877-523-7325 or email: customerservice@laerdal.com , referencing the following number: 2017-R-05.
Quantity in Commerce 204
Distribution Nationally
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JCX and Original Applicant = PLAXTRON INDUSTRIAL (M) SDN. BHD.
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