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Terminated

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

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.

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