Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
FDA Recall Z-2488-2020 · Posted None
Recalling FirmProdimed Plastimed Division
Recall StatusTerminated
Product CodeEOQ
Date Initiated2020-05-27
Date Terminated2021-03-29
Product Quantity39800
Reason for Recall
Lack of assurance of sterility
Firm 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: [email protected], 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: [email protected] or by phone: +33 2 37 65 86 20
Root Cause
Process control
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.