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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Product Detail

Product Description 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod®, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
Recall Number Z-0055-2013
Classification Class II
Code Info Part Number (Item #) AG8049-NS, Lot # 2528655.
Product Distributed Qty 60
Reason For Recall 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.

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 Letter
Distribution Pattern Nationwide distribution: Virginia only.