FDA Medical Device Recalls (openFDA)
Prodimed Plastimed Division: Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
- Recall number
- Z-2490-2020
- Recalling firm
- Prodimed Plastimed Division
- Product
- Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
- Status
- Terminated
- Initiated
- 2020-05-27
- Posted
- not on file
- Terminated
- 2021-03-29
- Reason
- Lack of assurance of sterility
- Root cause
- 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
- 1460
- Distribution
- Nationwide
- Lot, serial or model codes
- All lots within expiry
- 510(k) numbers
- ["K974642"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 3003781614
- Firm city
- Le Plessis Bouchard
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28