Stryker Sustainability Solutions — Class II: BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Stryker Sustainability Solutions has initiated a Class II recall of the BARD Dynamic Tip Steerable (Product Number 6DYNTP001) due to reports of incomplete seals on the sterile product packaging.
This recall affects Stryker Sustainability Solutions, healthcare providers utilizing BARD Dynamic Tip Steerable devices, and departments responsible for sterile processing and inventory management.
An incomplete seal compromises the sterile barrier of a medical device, posing a potential risk of patient infection or device contamination. This suggests a possible failure in the manufacturing or packaging validation process, requiring a review of sterility assurance levels and post-market quality control measures.
QA teams should immediately verify inventory for Product Number 6DYNTP001 and secure affected units. Regulatory and manufacturing personnel should review seal validation protocols and visual inspection criteria for sterile barrier integrity to prevent recurrence.
Class II. Reason: Incomplete seals on sterile product. Product: BARD Dynamic Tip Steerable, Product Number 6DYNTP001;. Firm: Stryker Sustainability Solutions (Tempe AZ United States). Status: Ongoing.
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