Boston Scientific Corporation — Class II: CRE Pro Wireguided 12-15mm 240cm
Boston Scientific Corporation has initiated a Class II recall for the CRE Pro Wireguided 12-15mm 240cm device due to a potential sterile breach in the product packaging pouches.
Boston Scientific Corporation and healthcare facilities utilizing the CRE Pro Wireguided 12-15mm 240cm dilator. It directly impacts departments responsible for device sterilization, packaging, and inventory management.
A breach in sterile packaging compromises the safety profile of a medical device and increases the risk of healthcare-associated infections. This ongoing recall suggests that existing packaging or manufacturing controls may have failed to ensure the integrity of the sterile barrier, potentially necessitating a review of pouch sealing processes or material specifications.
Quality and supply chain teams should identify and quarantine affected CRE Pro Wireguided inventory. QA should evaluate existing sterile barrier validation and pouch integrity testing protocols to investigate the root cause of the breach. Regulatory teams must monitor the ongoing status of this recall for potential updates to the scope or classification.
Class II. Reason: Potential sterile breach of the pouches in which devices are packaged.. Product: CRE Pro Wireguided 12-15mm 240cm. Firm: Boston Scientific Corporation (Marlborough MA United States). Status: Ongoing.
Open in openFDA / FDA.gov