AB HiResolution Bionic Ear System recall: Impurity Out of Spec
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to…
Why was AB HiResolution Bionic Ear System recalled?
hearing performance degradation due to body-fluid entering the device.
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?
Model Numbers: CI 1600 04 - HiRes Ultra with HF Mid-Scala Electrode CI 1600 05 - HiRes Ultra with HF Mid-Scala Electrode Lot Numbers - 1000000 thru 1999999.
- Product
- AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to…
- Recalling firm
- Advanced Bionics, LLC
- Quantity
- 14068 units (CI-1600-04 = 9772 units and CI-1600-05 = 4296 units)
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China, Australia, India, South Korea, Thailand, Ecuador, Mexico, El Salvador, Guatemala, Malaysia, Myanmar, Taiwan, Chile, Costa Rica, Colombia, Panama, Japan, Argentina, Peru, Singapore, China, New Zealand, Vietnam, Dominican Republic Refer to uploaded consignee lists in Associated Documents: Exhibit 05_ConsigneeList_Center_17FEB2020 Exhibit 06_ConsigneeList_Professionals_17FEB2020 Exhibit 07_ConsigneeList_Patients_17RFEB2020
- Recall date
- May 27, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)