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Recall Observatory FDA recall evidence

Device product

ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

Z-2725-2020

June 30, 2020

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 85983
Status
Ongoing
Classification
Class II
Quantity
680 units
Official record key
device-enforcement:Z-2725-2020

Official wording

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

Code information: Model: DYNCPTP14T, Lot #6918100021:

Distribution pattern: US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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