AVID Medical, Inc. — Class II: Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience ki
AVID Medical, Inc. has initiated a Class II recall for the Halyard STANDARD LINE INSERTION PACK (Model PVHM234-01) due to defects in the silicone seal. These defects may cause 'doming' from improper sealing, which can result in fluid occlusion or leakage.
This affects AVID Medical, Inc., healthcare facilities utilizing these specific insertion packs, and professionals in quality control, procurement, and clinical supply management.
The defect indicates a failure in the sealing process of a component within a convenience kit, which could compromise functional performance during clinical procedures. For regulatory professionals, this underscores the importance of process validation for silicone components and the potential for secondary packaging or assembly issues to trigger post-market enforcement actions.
Quality teams should verify inventory for the specified catalog number and assess existing inspection protocols for silicone seal integrity. Regulatory and QA departments should ensure that risk documentation accounts for potential fluid occlusion or leakage stemming from manufacturing seal defects.
Class II. Reason: Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.. Product: Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.. Firm: AVID Medical, Inc. (Toano VA United States). Status: Ongoing.
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