RecallDepth

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.

Company
Medline Industries Inc
Recall Initiated
June 30, 2020
Recall Number
Z-2725-2020
Quantity
680 units
Firm Location
Northfield, IL

Reason for Recall

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

Distribution

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

Lot / Code Info

Model: DYNCPTP14T, Lot #6918100021:

Root Cause

Process control

Action Taken

Customer letter dated 06/29/2020 was issued to consignees. Consignees are asked to check their inventory for impacted product and destroy affected product. Consignees are asked to complete and return a destruction form listing quantity of affected product destroyed or indicate no product was on hand. Additionally, if product has been further distributed, consignees are asked to notify those customers who may be impacted.

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