Anspach Effort SC2100 Foot Control Recalled for Missing Service Interval
The Anspach Effort, Inc. is recalling 22 SC2100 foot controls because the supplied directions for use did not contain a recommended service interval.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a missing service interval in the documentation without reporting any injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 22 units of the Foot Control without Switches, SC2100. The product is used in electric systems. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected units were distributed worldwide, including US Nationwide in the states of HI and DC, Puerto Rico, Guam, and Japan. The recall covers all product shipped prior to 09/27/2016. The specific product code is DFU 18-0085 and Part No. EPLUS-FP-NS.
Consumers who possess this product should contact The Anspach Effort, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Foot Control without Switches, SC2100 Product Usage: Electric system
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Foot Control
- Hazard
- Affected units
- 22
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)
- All product shipped prior to 09/27/2016
- DFU 18-0085
- Part No. EPLUS-FP-NS.
Distribution
Part of a larger recall action
This product is one of 103 recalled by The Anspach Effort, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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