Medline Recalls ClearPro T-Piece Closed Suction Catheters Due to Assembly Failure
Medline Industries is recalling 2,440 units of ClearPro T-Piece Closed Suction Catheters because reports indicate 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a mechanical failure (catheter coming apart) during use without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries Inc is recalling 2,440 units of ClearPro T-Piece Closed Suction Catheters, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE. The recall is being conducted because there are reports of the suction catheter coming apart from the device assembly during use. These catheters are intended for endotracheal suction of adult patients with artificial airways and are for single use only.
The affected units are identified by Lot #6919020016. The products were distributed nationwide in the United States, including in the states of Arkansas, Arizona, California, Florida, Georgia, Illinois, Mississippi, New York, Nevada, Ohio, Pennsylvania, and Texas.
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 recalled products.
The recalled product
- Product
- ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
- Manufacturer
- Medline Industries Inc
- Affected units
- 2,440
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: DYNCPTP14
- Lot #6919020016:
Distribution
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.
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