Behind-the-ear sound processer packaging label is different then included product.
Behind-the-ear sound processer packaging label is different then included product.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Advanced Bionics, LLC or your healthcare provider for instructions. Notification method: Letter
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Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150. Reason: Behind-the-ear sound processer packaging label is different then included product.. Classification: Class II. Quantity: 2 units. Distribution: Unknown
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Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Defective container; inadequately sealed blister packaging.