The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1459-2017·Announced 2017-03-22

Terumo Level Sensor Gel Pads Recalled for Non-Compliant Labeling

Terumo is voluntarily recalling Level Sensor II Gel Pads because the expiration date format may not be recognizable to all users.

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 2/5 (Moderate).

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 and involves a minor labeling error regarding the expiration date format, which fits the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Terumo Cardiovascular Systems Corporation has initiated a voluntary recall of the Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads. The recall is due to non-compliant labeling, specifically because the product expiration date is displayed in a format that may not be recognizable to all users.

The affected products are Level Sensor II Gel Pads, Catalog No. 217390, with UDI No. 00886799000519. The recall covers lot numbers ranging from 782300 through 817488, which were manufactured between November 19, 2015, and November 25, 2016, and distributed between November 23, 2015, and December 15, 2016. A total of 3,794 units were distributed.

These products were distributed worldwide, including nationwide in the United States and in various international locations such as Canada, Mexico, Australia, and several countries in Asia and Europe. The gel pads are used to attach level sensors to a hard shell reservoir and include coupling gel. Users should check their inventory for the specific catalog and lot numbers listed and contact the manufacturer for further instructions.

The recalled product

Product
Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Perfusion Accessories
Hazard
Affected units
3,794

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 (6)

  • Level Sensor II Gel Pads
  • Catalog No. 217390
  • UDI No: 00886799000519
  • Lot Numers Ranging from 782300 through 817488
  • Manufactured from 19-Nov-2015 to 25-Nov-2016
  • Distributed from 23-Nov-2015 through 15-Dec-2016.

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Terumo Cardiovascular Systems Corporation 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 2 products in this recall →

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