Anspach Effort 16cm Minimally Invasive Attachment Pneumatic System Recall
The Anspach Effort, Inc. is recalling 177 units of the 16cm Minimally Invasive Attachment because the supplied directions for use did not contain a recommended service interval.
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, and the hazard involves a documentation issue (missing service interval) rather than a direct physical defect or reported injury, fitting the Moderate severity criteria for minor labeling/documentation errors.
Plain-English summary
The Anspach Effort, Inc. is recalling 177 units of the 16cm Minimally Invasive Attachment, a pneumatic system. 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 US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan. The recall includes all serial numbers shipped to customers prior to 09/27/2016, identified by DFU 18-0048 and Part No. MIA16.
Consumers should contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- 16cm Minimally Invasive Attachment Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 177
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 serial numbers shipped to customers prior to 09/27/2016
- DFU 18-0048
- Part No. MIA16.
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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