The Recall Desk
LowFDA (Devices)·Z-2029-2017·Announced 2017-05-10

Anspach Effort 5.0cm Short Attachment Recalled for Missing Service Interval

The Anspach Effort, Inc. is recalling 5,757 units of the 5.0cm Short Attachment 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 specific hazard is a documentation issue (missing service interval) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.

Plain-English summary

The Anspach Effort, Inc. is recalling 5,757 units of the 5.0cm Short Attachment. The recall is due to a documentation issue where 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, with DFU 18-0048 and Part No. SHORT. The products were distributed worldwide, including US Nationwide in the states of HI, 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.

The recalled product

Product
5.0cm Short Attachment
Affected units
5,757

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. SHORT.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 103 products in this recall →