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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description Normoflo Irrigation Fluid Warmer Reorder Number: H-1100 230V
Recall Number B-1053-13
Classification Class II
Code Info Serial Numbers: S105B00009, S105B00010, S105B00011, S105B00012, S105B00015, S105B00016, S105B00017, S105B00018, S105B00019, S105B00020, S105B00021, S105B00022, S105B00024, S105B00027, S105B00028, S105B00032, S105B00041
Product Distributed Qty 17 Units -OUS
Reason For Recall Level 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed.

Event Detail

Event Id 64211
Product Type Biologics
Status Ongoing
Recalling Firm Smiths Medical ASD, Inc.
City Rockland
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Foreign: Canada, Mexico, Santo Domingo, Panama, Equador, Chile, Portugual, Qatar, Ireland, Libiya, UAE, Great Britain, India,Germany, Italy, Oman. Belgium, Netherlands, Switzerland, Australia, Austria, Poland, Romania, Hungary, Vietnam,Egypt, Japan, Spain