Anspach Custom Device Autolube III Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Device Autolube III 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 hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling its Anspach Custom Device Autolube III, modified with a swivel. The recall is due to the units not being manufactured consistently with Quality System requirements.
The affected units are identified by Part Number 98-0056 and Serial Number 30978704. These devices are intended to be used with Anspach Systems and are prescription-only. The distribution included the United States (specifically AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, and 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***REF-98-0056***Custom Device Autolube III modified with a swivel***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: 98-0056
- Serial Number: 30978704
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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