Z-2725-2020Class II

ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE -

Name: Z-2725-2020 ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE -
Creator: Medline Industries Inc
Published: 2020-06-30
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-06-30 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal... on 2020-06-30. FDA classified it as Class II and gives the reason as "There are reports of the suction catheter coming apart from the device assembly during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2725-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-30
Posted: 2020-07-28
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY 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 are reports of the suction catheter coming apart from the device assembly during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customer letter dated 06/29/2020 was issued to consignees. Consignees are asked to check their inventory for impacted product and destroy affected product. Consignees are asked to complete and return a destruction form listing quantity of affected product destroyed or indicate no product was on hand. Additionally, if product has been further distributed, consignees are asked to notify those customers who may be impacted.
Quantity in commerce: 680 units
Distribution: US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.
Product codes and lots: Model: DYNCPTP14T, Lot #6918100021:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2725-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2724-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-05	2020-07-28
Z-2725-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-05	2020-07-28

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)