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U.S. Department of Health and Human Services

Class 2 Device Recall Prodimed Combicath catheters

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  Class 2 Device Recall Prodimed Combicath catheters see related information
Date Initiated by Firm May 27, 2020
Create Date July 04, 2020
Recall Status1 Terminated 3 on March 29, 2021
Recall Number Z-2490-2020
Recall Event ID 85776
510(K)Number K974642  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm
Product Code: 58229 19
Code Information All lots within expiry
Recalling Firm/
Manufacturer
Prodimed Plastimed Division
3 Rue Louis Armand
Le Plessis Bouchard France
Manufacturer Reason
for Recall
Lack of assurance of sterility
FDA Determined
Cause 2
Process control
Action Prodimed notified the Distributor by phone and email on 5/27/20 stating reason for recall, health risk, and action to take: Actions to be taken: 1. Immediately examine your inventory and quarantine product subject to recall. 2. In addition, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of the attached Sub-Recall communication. This recall should be carried out to the user level. 3. Send back the response form completed, dated and signed as soon as possible by email to: customer-service@prodimed.com, or by fax: +33 23746388. 4. Make a weekly report to keep Prodimed informed of the progress of the recall. 5. After agreement of our Export Customer Service, proceed to the destruction of the recalled products quarantined (including products returned by your customers) in front of judicial officer with statement of destruction. If you have any questions, contact the customer service on the following email: customerservice@prodimed.com or by phone: +33 2 37 65 86 20
Quantity in Commerce 1460
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 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 = PLASTIMED LABORATOIRE PHARMACEUTIQUE
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