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 | Devices |
| 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 |
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