Z-0058-2021 Class II Terminated
FDA device recall Z-0058-2021 was initiated by Medline Industries Inc on September 1, 2020 and is designated Class II. Reason for recall: There have been reports of the suction catheter coming apart from the device assembly during use. The recall status is terminated (terminated May 27, 2022). Affected quantity: 6225 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2020
- Initiation Date
- September 1, 2020
- Termination Date
- May 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6225 units
Product Description
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.
Reason for Recall
There have been reports of the suction catheter coming apart from the device assembly during use.
Distribution Pattern
62 US consignees; 1 government consignee, 4 foreign consignees
Code Information
Model: DYNCPDS14T, Lots 06919010016 and 06919020016