Z-2395-2012 Class II Terminated
FDA device recall Z-2395-2012 was initiated by Hospira Inc. on Aug 28, 2012 and is designated Class II. Reason for recall: Embedded iron oxide glass defect which may have the potential to break off into the solution. The recall status is terminated (terminated Sep 18, 2013). Affected quantity: 191,094 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 26, 2012
- Initiation Date
- Aug 28, 2012
- Termination Date
- Sep 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 191,094 units
Product Description
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Reason for Recall
Embedded iron oxide glass defect which may have the potential to break off into the solution.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2395-2012
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026