Z-2395-2012Class II

Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible...

Name: Z-2395-2012 Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible...
Creator: Hospira Inc.
Published: 2012-08-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-08-28 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections on 2012-08-28. FDA classified it as Class II and gives the reason as "Embedded iron oxide glass defect which may have the potential to break off into the solution". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2395-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-28
Posted: 2012-09-17
Terminated: 2013-09-18
Recalling firm: Abbott Medical
Product: Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Product code: KPE Container, I.V.
Reason for recall: Embedded iron oxide glass defect which may have the potential to break off into the solution.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Hospira sent an "URGENT DEVICE RECALL" dated August 28, 2012 to all affected customers. The letter identified the product, problem,and actions to be taken by the customers. The letter included an Urgent Device Recall Reply Form for customers to complete and return via fax to 1-888-237-5582. Contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.
Quantity in commerce: 191,094 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2395-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2395-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-17

Product code KPE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)