Recalls / —
—#183680
Product
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.
- FDA product code
- BSY — Catheters, Suction, Tracheobronchial
- Device class
- Class 1
- Medical specialty
- Anesthesiology
- Affected lot / code info
- Model: DYNCPDS14T, Lots 06919010016 and 06919020016
Why it was recalled
There have been reports of the suction catheter coming apart from the device assembly during use.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Medline Industries Inc
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Distribution pattern
- 62 US consignees; 1 government consignee, 4 foreign consignees
Timeline
- Recall initiated
- 2020-09-01
- Terminated
- 2022-05-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #183680. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.