Enforcement Report - Week of February 27, 2013
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Product Detail
| Product Description | CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein. |
|---|---|
| Recall Number | Z-0832-2013 |
| Classification | Class II |
| Code Info | Lot number 12055225 |
| Product Distributed Qty | 5,050 units |
| Reason For Recall | CareFusion is recalling the SmartSite® Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment. |
Event Detail
| Event Id | 64204 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Carefusion 303 Inc |
| City | San Diego |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-20 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT. |
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