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 |
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