Agency classClass IIOur severity:Severe FDA (Devices)·Z-2725-2020·Announced 2020-08-05

Medline Recalls ClearPro Trach T-Piece Closed Suction Catheters

Medline is recalling 680 units of ClearPro Trach T-Piece Closed Suction Catheters because the catheter may come apart from the device assembly during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device used for airway management, which poses a significant risk of injury.

Plain-English summary

Medline Industries Inc is recalling 680 units of ClearPro Trach T-Piece Closed Suction Catheters, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE. The recall was initiated due to reports that the suction catheter may come apart from the device assembly during use.

The affected product is intended for endotracheal suction of adult patients with artificial airways and is for single use only. The recall covers Lot #6918100021. The products were distributed nationwide in the United States, including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, and TX.

Healthcare facilities and consumers should stop using the affected catheters immediately. Users should contact Medline Industries Inc for further instructions on how to return or dispose of the product.

The recalled product

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.
Manufacturer: Medline Industries Inc
Category: Medical Device — Respiratory / Airway Management
Hazard: structural-defect
device-separation
Affected units: 680

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Model: DYNCPTP14T
Lot #6918100021:

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Medline Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Medline Industries Inc

See all →

High
Medline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
Moderate
Medline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
Moderate
Bedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
High
Medline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
High
EVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22

Same hazard · structural defect