Recall Z-2490-2020 ยท EOQ Bronchoscope (Flexible Or Rigid)
Prodimed Plastimed Division
Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
| Date | May 27, 2020 |
| Status | Terminated |
| 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@prod |
| Quantity | 1460 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974642 | COMBICATH CATHETER Plastimed Laboratoire Pharmaceutique, Mar 13, 1998 |