Anspach Effort Recalls IMRI Motor Pneumatic System Due to Missing Service Interval
The Anspach Effort, Inc. is recalling three IMRI Motor pneumatic systems 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 classified as FDA Class II, but the hazard is strictly a documentation issue (missing service interval) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
The Anspach Effort, Inc. is recalling three IMRI Motor pneumatic systems. The recall is due to a documentation error where the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected units were distributed worldwide, including in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. The recall covers all product shipped prior to September 27, 2016, identified by DFU 18-0093 and Part No. IMRI-MOTOR.
Consumers and healthcare facilities should contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- IMRI MOTOR Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- 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 (3)
- All product shipped prior to 09/27/2016
- DFU 18-0093
- Part No. IMRI-MOTOR
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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