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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 Level 1 Fast Flow Fluid Warmer's without air detection Reorder Number: H-1000 100V, 115V and Level Fast Flow Fluid Warmer's without air detection 230V
Recall Number B-1051-13
Classification Class II
Code Info Serial Numbers: S104C00013, S104C00014, S104C00015, S104C00016, S104C00019, S104C00020, S104C00021, S104C00022, S104C00023, S104C00024, S104C00025, S104C00026, S104C00027, S104C00028, S104C00029, S104C00030, S104C00031, S104C00032, S104C00033, S104C00034, S104C00035, S104C00036, S104C00037, S104C00038, S104C00039, S104C00040, S104C00041, S104C00042, S104C00043
Product Distributed Qty 29 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