Medline Recalls ClearPro Closed Suction Catheters Due to Assembly Separation
Medline Industries is recalling 6,225 ClearPro Closed Suction Catheters because the catheter may separate 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. The hazard involves a structural defect in a medical device used on patients with artificial airways, which presents a risk of harm, but the source text does not report specific injuries or fatalities.
Plain-English summary
Medline Industries Inc is recalling 6,225 units of ClearPro Closed Suction Catheters, Model DYNCPDS14T, 14 Fr. The affected units are identified by Lots 06919010016 and 06919020016. These catheters are intended for endotracheal suction of adult patients with artificial airways and are for single use only.
The recall was initiated due to reports that the suction catheter may come apart from the device assembly during use. This defect poses a risk of injury to patients if the catheter separates while in use.
The affected products were distributed to 62 US consignees, 1 government consignee, and 4 foreign consignees. Healthcare facilities and consumers should stop using the affected units and contact Medline Industries for further instructions.
The recalled product
- 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.
- Manufacturer
- Medline Industries Inc
- Affected units
- 6,225
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: DYNCPDS14T
- Lots 06919010016 and 06919020016
Distribution
Distribution scope not specified by the agency.
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