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Recall Observatory FDA recall evidence

Device 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.

Z-0058-2021

September 01, 2020

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 86423
Status
Terminated
Classification
Class II
Quantity
6225 units
Official record key
device-enforcement:Z-0058-2021

Official wording

Reason: There have been reports of the suction catheter coming apart from the device assembly during use.

Code information: Model: DYNCPDS14T, Lots 06919010016 and 06919020016

Distribution pattern: 62 US consignees; 1 government consignee, 4 foreign consignees

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There have been reports of the suction catheter coming apart from the device assembly during use.