Anspach Effort Recalls eMax2 Hybrid Hand Control for Missing Service Interval
The Anspach Effort, Inc. is recalling 293 eMax2 Hybrid Hand Controls because the supplied directions for use did not contain a recommended service interval.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (missing service interval in the Directions for Use) with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
The Anspach Effort, Inc. is recalling 293 units of the eMax2 Hybrid Hand Control, an electric system product. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected products were distributed worldwide, including in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. The recall includes all product shipped prior to September 27, 2016, identified by DFU 18-0085 and Part No. eMax2-HC.
Consumers who have this product should contact The Anspach Effort, Inc. for further instructions on how to proceed.
The recalled product
- Product
- eMax2 Hybrid Hand Control Product Usage: Electric system
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Hand Control
- Hazard
- Affected units
- 293
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 (3)
- All product shipped prior to 09/27/2016
- DFU 18-0085
- Part No. eMax2-HC.
Distribution
Part of a larger recall action
This product is one of 103 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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