Medline Industries, LP — Class II: Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ
Medline Industries, LP is recalling specific sinus pack convenience kits that include Healthmark Instrument Channel Brushes. These brushes were previously recalled by their original manufacturer due to sharp edges or burrs that pose risks of cut injuries, abrasions, and infection.
This recall affects Medline Industries, LP, healthcare providers utilizing SINUS PACK DYNJ48258D and DYNJ48258F, and departments responsible for surgical kit procurement and sterilization.
This incident highlights the regulatory risks inherent in convenience kit assembly, where a recall of a single third-party component necessitates a recall of the entire multi-component kit. Regulatory teams must ensure robust supplier monitoring programs are in place to quickly respond when sub-component manufacturers issue safety alerts.
Regulatory and supply chain teams should immediately identify and quarantine the specified sinus packs. QA should verify the integrity of secondary components in other convenience kits and update inventory controls to prevent the distribution of recalled sub-components.
Class II. Reason: Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.. Product: Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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