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