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Recall Observatory FDA recall evidence

Device product

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

Z-2070-2014

June 05, 2014

Class II

Product summary

Firm
Excelsior Medical Corp
Event
Event 68573
Status
Terminated
Classification
Class II
Quantity
4250 tubing sets (PA03 - 78 cases; BX03 - 92 cases (each case contains 25 tubing sets))
Official record key
device-enforcement:Z-2070-2014

Official wording

Reason: 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.

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

Distribution pattern: Worldwide Distribution - USA (nationwide) and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.