Z-2724-2020 Class II Ongoing
FDA device recall Z-2724-2020 was initiated by Medline Industries Inc on June 30, 2020 and is designated Class II. Reason for recall: There are reports of the suction catheter coming apart from the device assembly during use. The recall status is ongoing. Affected quantity: 2440 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- June 30, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2440 units
Product Description
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.
Reason for Recall
There are reports of the suction catheter coming apart from the device assembly during use.
Distribution Pattern
US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.
Code Information
Model: DYNCPTP14, Lot #6919020016: