Medline Imaging Biopsy Tray and Breast Biopsy Pack recalled for defective lidocaine ampules
What this means
Medline's Imaging Biopsy Tray (Model DYNDH1068) and Breast Biopsy Pack (Model PHS234706I) contain lidocaine ampules that were identified as defective during an FDA manufacturing inspection. The ampules were supplied by Huons Co., Ltd. and may not meet quality standards. Approximately 40 kits are affected nationwide.
- Check if you have one of the affected kits (Model DYNDH1068 or PHS234706I with the listed lot numbers).
- Stop using the kits and contact Medline or your supplier for instructions on return or replacement.
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-2539-2026More Medline recalls
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