Anspach Effort Recalls System Consoles for Missing Service Interval Instructions
The Anspach Effort, Inc. is recalling 462 System Console 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because the hazard is a documentation issue (missing service interval) with no reported injuries or illnesses, fitting the rubric criteria for cosmetic or documentation defects.
Plain-English summary
The Anspach Effort, Inc. is recalling 462 units of the System Console, Single Port, with irrigation (Part No. SC2101). The recall is due to a documentation issue where 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 HI and DC), Puerto Rico, Guam, and Japan. The recall covers all product shipped prior to 09/27/2016, identified by DFU 18-0085.
Consumers and healthcare facilities should check their inventory for this specific part number and DFU version. If the product matches the description, they should stop using it and contact The Anspach Effort, Inc. for further instructions.
The recalled product
- Product
- System Console, Single Port, with irrigation Product Usage: Electric system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 462
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. SC2101.
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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