Enforcement Report - Week of August 1, 2012
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Product Detail
| Product Description | Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids. |
|---|---|
| Recall Number | Z-2075-2012 |
| Classification | Class II |
| Code Info | list 12722-65, lot number 96-098-5H |
| Product Distributed Qty | 4,420 sets |
| Reason For Recall | The float valve in the burette sticks to the burette wall and does not open or close properly. |
Event Detail
| Event Id | 62582 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Hospira Inc. |
| City | Lake Forest |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-13 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution-USA (nationwide) including the states of California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Massachusetts, Minnesota, Oklahoma, Texas, Utah, Virginia, Washington, West Virginia and Wyoming, and the countries of Barbados and Canada. |
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