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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus MAJ209 SingleUse Suction Valve (MAJ209)

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  Class 2 Device Recall Olympus MAJ209 SingleUse Suction Valve (MAJ209) see related information
Date Initiated by Firm April 01, 2019
Create Date August 02, 2019
Recall Status1 Terminated 3 on June 09, 2020
Recall Number Z-2148-2019
Recall Event ID 82519
510(K)Number K920025  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209

Product Usage:
This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.
Code Information Lot numbers: 88H, 89H, 8XH, 8YH, 8ZH, 91H
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms
484-896-5000
Manufacturer Reason
for Recall		 There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
FDA Determined
Cause 2		 Process control
Action Urgent Medical Device Correction letters dated 4/1/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions call 484-896-5688.
Quantity in Commerce 310000
Distribution The products were distributed US 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 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 = EOQ and Original Applicant = OLYMPUS CORP.
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