Stryker Sustainability Solutions — Class II: BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions has initiated a Class II recall for BARD Dynamic Deca Steerable reprocessed electrophysiology catheters (Product Number 201101) due to reports of incomplete seals on the sterile packaging.
This recall affects Stryker Sustainability Solutions, healthcare facilities utilizing reprocessed electrophysiology catheters, and hospital departments involved in sterile processing and cardiac electrophysiology.
An incomplete seal compromises the sterile barrier of a medical device, which may lead to healthcare-associated infections or procedural delays. For firms specializing in device reprocessing, this suggests a potential failure in the final packaging or seal validation phases of the manufacturing process. Regulatory professionals should note this as a critical quality control point for maintaining device integrity throughout the distribution chain.
QA and Sterility Assurance teams should review validation protocols for pouch/tray sealing processes, especially for reprocessed single-use devices. Facilities utilizing these specific reprocessed catheters should immediately verify inventory against the affected product number and follow manufacturer instructions for quarantine or return.
Class II. Reason: Incomplete seals on sterile product. Product: BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER. Firm: Stryker Sustainability Solutions (Tempe AZ United States). Status: Ongoing.
Open in openFDA / FDA.gov