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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Event Detail

Event ID 63362
Product Type Devices
Status Ongoing
Recalling Firm ICU Medical, Inc.
City San Clemente
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution: Virginia only.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod®, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system. Part Number (Item #) AG8049-NS, Lot # 2528655. Class II ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set. 60 Z-0055-2013