Anspach Modified MDA Tube Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Modified MDA Tubes with MA-D20 Attachments 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. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to manufacturing consistency rather than a specific acute safety defect like fire or shock, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling its Modified MDA Tube with MA-D20 Attachment (Part Number: 98-0019; Serial Number: 200422). The recall was initiated because the units were not manufactured consistently with Quality System requirements.
The affected devices are prescription-only and intended to be used with Anspach Systems. The distribution pattern includes the United States (specifically AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, and TX) and international locations including Canada, Japan, Hungary, Korea, and Sweden.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice. No illnesses, injuries, or deaths are reported in the source text.
The recalled product
- Product
- ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- 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: 98-0019
- Serial Number: 200422
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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