Medline arterial access and line insertion kits recalled for Lidocaine quality defects
What this means
Medline's arterial access and line insertion kits contain Lidocaine ampules from Huons Co., Ltd. that have quality defects. The defects were identified during an FDA inspection of the Lidocaine manufacturer's facility. The affected kits were distributed nationwide.
- Check if your facility has any of the recalled kits (Model ART1145, ART155A, or ART1010B with lot numbers ending in 90, 0590, or 0890).
- Do not use the Lidocaine ampules from the recalled kits.
- Contact Medline for instructions on returning or replacing affected kits.
The agency's original wording
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2533-2026More Medline recalls
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