Terumo Level Sensor II Pads Recalled for Non-Compliant Expiration Date Labeling
Terumo Cardiovascular Systems Corporation is voluntarily recalling Level Sensor II Pads because the expiration date format may not be recognizable to all users.
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 Moderate because it involves a minor labeling error (expiration date format) and is a voluntary precautionary recall with no reported injuries or illnesses.
Plain-English summary
Terumo Cardiovascular Systems Corporation has initiated a voluntary recall of Terumo Advanced Perfusion System 1-Level Sensor II Pads. These pads are ultrasonic couplants used to facilitate the transmission of sound energy between the level sensor and the reservoir in perfusion systems.
The recall was initiated due to non-compliant labeling. Specifically, the product expiration date is displayed in a format that may not be recognizable to all users, which could lead to the use of expired product.
The affected products include Level Sensor II Pads with Catalog No. 195240 and UDI No. 10886799001704. The lot numbers range from 782300 through 817488. These units were manufactured between November 20, 2015, and November 25, 2016, and distributed between November 23, 2015, and December 15, 2016. A total of 208,560 units were distributed nationwide in the United States and internationally to countries including Mexico, Australia, Canada, and others. Users should check their inventory for these specific lot numbers and contact the manufacturer for instructions.
The recalled product
- Product
- Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 208,560
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 Pads
- Catalog No. 195240
- UDI No: 10886799001704
- Lot Numers Ranging from 782300 through 817488
- Manufactured from 20-Nov2015 to 25-Nov-2016
- Distributed from 23-Nov-2015 through 15-Dec-2016.
Distribution
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.
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