Anspach Custom Device SC2102 Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Device SC2102 units because they were not manufactured consistently with Quality System requirements.
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 does not report any illnesses, injuries, or specific safety hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling its Anspach Custom Device SC2102 with fast stop firmware. The recall involves units with Part Number 98-0037 and Serial Number 2000940. These devices are prescription-only and are intended to be used with Anspach Systems.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The source text does not specify the exact nature of the manufacturing inconsistencies or any specific safety hazards associated with the defect.
The affected units were distributed worldwide, including in the United States (AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Custom Device
- Affected units
- 1
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 (2)
- Part Number: 98-0037
- Serial Number: 2000940.
Distribution
Part of a larger recall action
This product is one of 45 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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