The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter
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Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A. Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.. Classification: Class II. Quantity: 105550 units. Distribution: Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
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Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
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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.