Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK
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) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) DYNJ0621189XModel UDI-DI: 10195327638566(each)Model 40195327638567(case)Model Lot Number: 25ILA890Model 2) PAIN1470AModel UDI-DI: 10193489957365(each)Model 40193489957366(case)Model Lot Number: 25JLA514Model 3) TVS4000LModel UDI-DI: 10195327223540(each)Model 40195327223541(case)Model Lot Number: 25JDB583Model 4) TVS4000LModel Lot Number: 25KDA180Model 5) TVS4000LModel Lot Number: 25KDB274UPC 10195327638566UPC 40195327638567UPC 10193489957365UPC 40193489957366UPC 10195327223540UPC 40195327223541Would 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.