B Braun Medical Inc — Class II: Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Numb
B. Braun Medical Inc. has initiated a Class II recall for the CESK HARRIS METHODIST (Model 555498) following notification from their supplier, Ferndale Laboratories, Inc., regarding potential cracking of the butyrate tubing in the Mastisol Liquid Adhesive component.
This affects B. Braun Medical Inc., healthcare facilities using the CESK HARRIS METHODIST kits, and quality/supply chain professionals managing component integrity for adhesive-based medical devices.
The defect involves a mechanical failure of the outer tubing which renders the product unusable. This highlights the regulatory risk inherent in multi-component kits where a sub-assembly or third-party component failure triggers a recall for the primary manufacturer's finished device. Manufacturing and QA teams may need to assess the durability of butyrate-based materials within their own supply chains.
QA teams should immediately verify if catalog number 555498 is in inventory and implement quarantine procedures. Supply chain managers should evaluate downstream impacts when critical components (like Mastisol) are sourced from third-party manufacturers currently under recall.
Class II. Reason: B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.. Product: Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: No. Firm: B Braun Medical Inc (Bethlehem PA United States). Status: Ongoing.
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