Anspach Effort AL-III-DISS Adapter Recall for Missing Service Interval
The Anspach Effort, Inc. is recalling five AL-III-DISS Adapters 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 FDA Class II, but the hazard is a documentation issue (missing service interval) with no reported injuries or illnesses, fitting the criteria for a Low severity score (documentation issues).
Plain-English summary
The Anspach Effort, Inc. is recalling five units of the AL-III-DISS Adapter, a component used in pneumatic systems. The recall is due to a documentation error where the supplied Directions for Use (DFU) did not include a recommended service interval.
The affected products 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 18-0040 and Part No. AUTOLUBE-III-DISS.
Consumers and healthcare facilities should stop using the affected adapters and contact The Anspach Effort, Inc. for instructions on how to proceed.
The recalled product
- Product
- AL-III-DISS Adapter Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 5
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 18-0040
- Part No. AUTOLUBE-III-DISS
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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