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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Event Detail

Event ID 66152
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 2013-08-30
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing. Lot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672. Class II CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years. 2,850 units Z-2281-2013
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