Stryker Sustainability Solutions — Class II: BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 2
Stryker Sustainability Solutions has initiated a Class II recall for the BARD EP XT Decapolar Steerable Diagnostic EP Catheter due to a potential breach in the sterile barrier on the straight seal side of the primary pouch.
This recall affects Stryker Sustainability Solutions, healthcare facilities utilizing reprocessed diagnostic EP catheters, and personnel responsible for sterile processing and inventory management.
A compromised sterile barrier introduces significant clinical risks, including particulate embolization, infection, or thrombus formation. From a regulatory perspective, this indicates a failure in packaging integrity or the sterilization validation process, requiring a thorough CAPA investigation to prevent recurrence in reprocessed steerable catheters.
QA teams should immediately verify inventory against the specified REF number and secure any units with compromised primary pouch seals. Regulatory and engineering teams should investigate the root cause of the seal breach to determine if this is a manufacturing defect or a packaging design failure.
Class II. Reason: Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.. Product: BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007. Firm: Stryker Sustainability Solutions (Tempe AZ United States). Status: Ongoing.
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