Home / Recalls / Excelsior Medical Corp / Z-2070-2014

Z-2070-2014 Class II Terminated

Recalled by Excelsior Medical Corp — Neptune, NJ

Recall Details

Product Type: Devices
Report Date: July 23, 2014
Initiation Date: June 5, 2014
Termination Date: August 19, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4250 tubing sets (PA03 - 78 cases; BX03 - 92 cases (each case contains 25 tubing sets))

Product Description

Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer

Reason for Recall

There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Canada.

Code Information

Product Code PA03 - Lot Nos.: 03030813, 03050813 and 03091213 Product Code BX03, Lot Nos.: 64031513, 64073113, 64081313, 64090513