Recalls / —

—#112479

Product

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

FDA product code

KPE — Container, I.V.

Device class

Class 2

Medical specialty

General Hospital

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm

Hospira Inc.

Address

275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern

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

Timeline

Recall initiated

2012-08-28

Posted by FDA

2012-09-17

Terminated

2013-09-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #112479. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.