Terumo Advanced Perfusion System 1-Level Sensor II Gel recall: Labeling Error
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…
Why was Terumo Advanced Perfusion System 1-Level Sensor II Gel recalled?
Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 3,794
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of: Mexico, AUSTRALIA, UNITED ARAB EMIRATES (UAE), Indonesia, Singapore, Taiwan, Thailand, COLOMBIA, CHILE, Vietnam, India, China, Malaysia, BELGIUM, Japan, CANADA
- Recall date
- March 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)