Anspach Custom MCA5-1SD Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 20 Anspach Custom MCA5-1SD devices 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 hospitalizations, and the defect is a manufacturing consistency issue rather than a direct safety hazard like a structural failure or contamination.
Plain-English summary
The Anspach Effort, Inc. is recalling 20 units of the Anspach Custom MCA5-1SD with Extended Exposure. These prescription-only devices are intended to be used with Anspach Systems. The recall is being conducted because the units were not manufactured consistently with Quality System requirements.
The affected devices have Part Numbers 98-0049 and 98-0051, and Serial Numbers 2000729 and 2000761. The products 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 specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 20
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 (4)
- Part Numbers: 98-0049
- 98-0051
- Serial Numbers: 2000729
- 2000761
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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