The Recall Desk
ModerateFDA (Devices)·Z-2001-2017·Announced 2017-05-10

Anspach Pneumatic Attachment Recalled for Missing Service Interval Instructions

The Anspach Effort, Inc. is recalling 9,829 pneumatic attachments because the supplied directions for use did not include a recommended service interval.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a documentation error (missing service interval) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling 9,829 units of the 12.4cm Heavy Duty Long Heavy Short Attachment (Part No. LONG-HD). This product is 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 DFU 18-0048 and include all serial numbers shipped to customers prior to September 27, 2016. The products were distributed worldwide, including nationwide in the United States (specifically HI and DC), Puerto Rico, Guam, and Japan.

Consumers who have this product should stop using it and contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.

The recalled product

Product
12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Pneumatic System Attachment
Hazard
Affected units
9,829

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. LONG-HD.

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 →

Related recalls

Same manufacturer · The Anspach Effort, Inc.

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Same hazard · missing instructions

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