Anspach Effort Recalls 10.5cm Angle Attachments Due to Missing Service Instructions
The Anspach Effort, Inc. is recalling 13 units of the 10.5cm Angle Attachment, Black Max, because the supplied directions for use did not include 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 due to a documentation issue (missing service interval in directions for use) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
The Anspach Effort, Inc. is recalling 13 units of the 10.5cm Angle Attachment, Black Max. The recall was initiated because the supplied directions for use (DFU) did not contain a recommended service interval.
The affected products are identified by Part No. B-QD11-S and DFU 18-0062. All serial numbers were shipped to customers. The distribution pattern includes worldwide distribution, specifically US Nationwide in the states of HI and DC, including PR, and the countries of Guam and Japan.
Consumers should stop using the product and contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- 10.5CM ANGLE ATTACHMENT, BLACK MAX
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 13
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-QD11-S.
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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