Terumo Sarns System 8000 Base Recalled for Incorrect Amperage Labeling
Terumo is recalling three Sarns System 8000 bases because they were distributed with incorrect amperage ratings on the nameplate labels.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a labeling error that was corrected in the field, fitting the criteria for a Low severity score.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling three Sarns System 8000 bases. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall was initiated after a retrospective review of complaint events identified that the units were manufactured and distributed between November 13, 2006, and November 29, 2006, with an incorrect amperage rating on the nameplate label. The mislabeling was identified in January 2007 during the setup process of the automark label printer. The affected units are catalog number 16401 with serial numbers 2001, 2002, and 2003.
The units were distributed nationwide, including New York. The source text notes that all units were corrected in the field in March, though the specific year is not fully legible in the provided excerpt. Users should verify the nameplate labels on their devices to ensure they match the correct specifications.
The recalled product
- Product
- System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- catalog number: 16401 and serial number: 2001
- 2002
- and 2003.
Distribution
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