Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I
Medline Industries, LP
The hazard
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) DYNDH1068Model UDI-DI: 10889942172122(each)Model 40889942172123(case)Model Lot Number: 2025101090Model 2) PHS234706IModel UDI-DI: 10198459330278(each)Model 40198459330279(case)Model Lot Number: 25JLB029UPC 10889942172122UPC 40889942172123UPC 10198459330278UPC 40198459330279Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.