Z-0058-2021Class II

ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE -

Name: Z-0058-2021 ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE -
Creator: Medline Industries Inc
Published: 2020-09-01
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-09-01 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult... on 2020-09-01. FDA classified it as Class II and gives the reason as "There have been reports of the suction catheter coming apart from the device assembly during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0058-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-01
Posted: 2020-10-06
Terminated: 2022-05-27
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: There have been reports of the suction catheter coming apart from the device assembly during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 6225 units
Distribution: 62 US consignees; 1 government consignee, 4 foreign consignees
Product codes and lots: Model: DYNCPDS14T, Lots 06919010016 and 06919020016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0058-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0058-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-06

Product code BSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)