Anspach Custom QD11 Attachment Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling three Custom QD11 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, but the source text does not report any injuries, illnesses, or specific safety hazards, aligning with the rubric for moderate severity involving quality system non-compliance without reported harm.
Plain-English summary
The Anspach Effort, Inc. is recalling three units of the Anspach Custom QD11 Attachment with thinner nose tube. The recall is limited to specific units identified by Part Numbers 98-0054 and 98-0055, and Serial Numbers 2000782, 2000783, and D51200085101. These devices are intended to be used with Anspach Systems and are prescription-only.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The source text does not report any specific injuries, illnesses, or adverse events associated with these devices.
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. Consumers and healthcare providers should check their inventory for the specific part and serial numbers listed above and stop using the affected devices.
The recalled product
- Product
- ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 3
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 (5)
- Part Number: 98-0054
- 98-0055
- Serial Numbers: 2000782
- 2000783
- D51200085101.
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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