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.
What this means for you
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 profe
- 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
Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corporation
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- HighTerumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
FDA (Devices) · 2025-04-09
- HighCardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
FDA (Devices) · 2024-04-10
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02