Anspach Effort SC2100 Foot Control Recalled for Missing Service Interval
The Anspach Effort, Inc. is recalling 320 SC2100 Foot Controls because the supplied directions for use did not contain a recommended service interval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 documentation issue.
Plain-English summary
The Anspach Effort, Inc. is recalling 320 units of the SC2100 Foot Control, an electric system component. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected products were distributed worldwide, including US Nationwide in the states of HI, DC, Puerto Rico, Guam, and Japan. The recall covers all product shipped prior to 09/27/2016, identified by DFU 18-0085 and Part No. EPLUS-FP.
Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Foot Control, SC2100 Product Usage: Electric system
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Foot Control
- Hazard
- Affected units
- 320
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.
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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