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.
- Company
- Medline Industries Inc
- Recall Initiated
- September 1, 2020
- Terminated
- May 27, 2022
- Recall Number
- Z-0058-2021
- Quantity
- 6225 units
- Firm Location
- Northfield, IL
Reason for Recall
There have been reports of the suction catheter coming apart from the device assembly during use.
Distribution
62 US consignees; 1 government consignee, 4 foreign consignees
Lot / Code Info
Model: DYNCPDS14T, Lots 06919010016 and 06919020016
Root Cause
Process control
Action Taken
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.