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Recall Observatory FDA recall evidence

Device product

Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.

Z-2395-2012

August 28, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 63078
Status
Terminated
Classification
Class II
Quantity
191,094 units
Official record key
device-enforcement:Z-2395-2012

Official wording

Reason: Embedded iron oxide glass defect which may have the potential to break off into the solution.

Code information: 250 mL size - Lot 11179DW, Exp, Date 1NOV2013, 11195DW, Exp. Date 1NOV2013 and 93854DW, Exp. Date 1SEP2012 - 1000 mL size - Lot 92835DW, Exp. Date 1AUG2012, Lot 96090DW, Exp. Date 1DEC2012, and Lot 96098DW, Exp. Date 1DEC2012

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Embedded iron oxide glass defect which may have the potential to break off into the solution.