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Terminated

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

FDA Recall Z-2395-2012 · Posted 2012-09-17

Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeKPE
Date Initiated2012-08-28
Date Terminated2013-09-18
Product Quantity191,094 units

Reason for Recall

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

Firm 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.

Root Cause

Material/Component Contamination

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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