Recall Z-0058-2021 ยท BSY Catheters, Suction, Tracheobronchial
Medline Industries Inc
ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
| Date | Sep 1, 2020 |
| Status | Terminated |
| Reason | There have been reports of the suction catheter coming apart from the device assembly during use. |
| Root cause | Process control |
| Action | Medline Industries, Inc. sent formal letters with response forms to each consignee affected via first class mail on 09/01/2020. Customers are asked to perform subrecalls as necessary. Consignees are asked to complete a response form a return via fax or email. Each response received will be recorded and subsequent letters will be initiated to non-responders. Recalled product at the consignee site should be destroyed at the consignee location per their local and state regulations. The recalling firm is not asking for product to be returned. |
| Quantity | 6225 units |
| Distribution | 62 US consignees; 1 government consignee, 4 foreign consignees |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.