FDAFDA · Food and drugs·Recall number Z-2070-2014
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
Published July 23, 2014 · Recall initiated: June 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Excelsior Medical Corp
- Distributor
- Worldwide Distribution - USA (nationwide) and Canada.
- Lot
- Product Code PA03 - Lot Nos.: 03030813, 03050813 and 03091213 Product Code BX03, Lot Nos.: 64031513, 64073113, 64081313, 64090513
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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