Medline Industries, LP — Class II: Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) N
Medline Industries, LP has initiated a Class II recall for four specific convenience kits due to the inclusion of a potentially contaminated component previously recalled by its original manufacturer. The recall is currently classified as ongoing and involves kits used in neurosurgical and craniotomy procedures.
This recall affects Medline Industries, LP, healthcare facilities utilizing these specific surgical kits, and personnel responsible for surgical supply chain and sterility assurance.
The recall highlights the regulatory risks inherent in convenience kit assembly, where the safety of the final product is dependent on the compliance of third-party component manufacturers. Quality units may need to assess their vendor management and sub-component tracking systems to ensure that upstream recalls are quickly identified and mitigated within finished kits.
Verify inventory against the specified SKUs (CDS982035Y, DYNJT6104, DYNJ903471I, DYNJ906496K). Quarantining affected kits and reviewing supplier notification logs for the sub-component recall is advised to ensure downstream safety.
Class II. Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer. Product: Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
Open in openFDA / FDA.gov