Anspach Effort Recalls IMRI Air Control Pneumatic Systems for Missing Service Info
The Anspach Effort, Inc. is recalling three IMRI Air Control pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 specific defect is a documentation issue (missing service interval) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling three units of the IMRI Air Control pneumatic system. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected product is identified by Part No. IMRI-FOOT-CTRL and DFU 18-0093. The recall covers all product shipped prior to 09/27/2016. Distribution was worldwide, including the US Nationwide in the states of HI, DC, Puerto Rico, Guam, and Japan.
Consumers should contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- IMRI AIR CONTROL 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-FOOT-CTRL
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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