Anspach Modified QD11 Attachment Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling six Modified 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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
The Anspach Effort, Inc. is recalling six units of the Anspach Modified QD11 Attachment with Soft Tissue Protector. The recall is being conducted because the units were not manufactured consistently with Quality System requirements.
The affected devices are prescription-only and are intended to be used with Anspach Systems. The recall includes units with Part Numbers 98-0013, 98-0014, and 98-0018, and Serial Numbers 20039501, 20039502, 20039601, 20039602, 20039701, and 20039702.
The devices 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. Users should contact the recalling firm for further instructions.
The recalled product
- Product
- ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 6
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 (8)
- Part Numbers: 98-0013
- 98-0014
- 98-0018. Serial Numbers: 20039501
- 20039502
- 20039601
- 20039602
- 20039701
- 20039702.
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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