Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
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) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) I550BF6CModel UDI-DI: 10653160339748(each)Model 00653160339741(case)Model Lot Number: 2025102290Model 2) I505BF9CModel UDI-DI: 10653160339687(each)Model 00653160339680(case)Model Lot Number: 2025093090UPC 10653160339748UPC 00653160339741UPC 10653160339687UPC 00653160339680Would 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.