Anspach Effort 6.8cm Controlled Depth Attachment Recalled for Missing Service Interval
The Anspach Effort, Inc. is recalling 6.8cm Controlled Depth Attachments because the supplied directions for use did not contain a recommended service interval.
What this means for you
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 6.8cm Controlled Depth Attachments used in pneumatic systems. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected units are identified by all serial numbers shipped to customers prior to 09/27/2016, DFU 18-0048, and Part No. CDA. 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 should contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- 6.8cm Controlled Depth Attachment Product Usage: Pneumatic system
- 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 prior to 09/27/2016
- DFU 18-0048
- Part No. CDA.
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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