Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2724-2020Class II

ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE -

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-06-30 / Open, Classified / root cause: manufacturing process

Medline Industries Inc began a recall of ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction... on . FDA classified it as Class II and gives the reason as "There are reports of the suction catheter coming apart from the device assembly during use". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2724-2020
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
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.
Product code
BSY Catheters, Suction, Tracheobronchial
Reason for recall
There are reports of the suction catheter coming apart from the device assembly during use.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
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.
Quantity in commerce
2440 units
Distribution
US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.
Product codes and lots
Model: DYNCPTP14, Lot #6919020016:

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2724-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2724-2020Class IIOngoingVoluntary: Firm initiated
Z-2725-2020Class IIOngoingVoluntary: Firm initiated