Anspach Effort Recalls 16CM Min Invasive Attach Due to Missing Service Interval
The Anspach Effort, Inc. is recalling 16CM Min Invasive Attach, Black Max units 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. The hazard is a documentation issue (missing service interval) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 16CM Min Invasive Attach, Black Max units. The recall was initiated because the supplied directions for use (DFU) did not contain a recommended service interval.
The recalled product is identified by Part No. B-GREY-MIA16 and DFU 18-0062. The quantity involved is 4 units. Distribution was worldwide, including US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan.
Consumers and healthcare facilities should stop using the affected units and contact The Anspach Effort, Inc. for further instructions.
The recalled product
- Product
- 16CM MIN INVASIVE ATTACH, BLACK MAX
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 4
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
- DFU 18-0062
- Part No. B-GREY-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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