Prodimed Plastimed Division 3 Rue Louis Armand Le Plessis Bouchard France Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Lack of assurance of sterility

Recommended Action

Per FDA guidance

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