FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0058-2021
- Recalling firm
- Medline Industries Inc
- 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.
- Status
- Terminated
- Initiated
- 2020-09-01
- Posted
- not on file
- Terminated
- 2022-05-27
- 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
- Lot, serial or model codes
- Model: DYNCPDS14T, Lots 06919010016 and 06919020016
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSY
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
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