Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A; 6) TRAY,CON EP
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) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A; 6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269; 7) EPIDURAL TRAY, Model Number: PAIN2278; 8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305; 9) CSE TRAY MEDLINE, Model Number: PAIN2334; 10) PNBT TRAY, Model Number: SAMPA0147
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) PAIN0072LModel UDI-DI: 10198459544163(each)Model 40198459544164(case)Model Lot Number: 25JDB100Model 2) PAIN1317Model UDI-DI: 10888277797109(each)Model 40888277797100(case)Model Lot Number: 25JLA788Model 3) PAIN1579AModel UDI-DI: 10193489422443(each)Model 40193489422444(case)Model Lot Number: 25JLA779Model 4) PAIN1885AModel UDI-DI: 10195327486310(each)Model 40195327486311(case)Model Lot Number: 25JLA861Model 5) PAIN1967AModel UDI-DI: 10198459241215(each)Model 40198459241216(case)Model Lot Number: 25JLA659Model 6) PAIN2269Model UDI-DI: 10198459342004(each)Model 40198459342005(case)Model Lot Number: 25JLA781Model 7) PAIN2278UPC 10198459544163UPC 40198459544164UPC 10888277797109UPC 40888277797100UPC 10193489422443UPC 40193489422444UPC 10195327486310UPC 40195327486311UPC 10198459241215UPC 40198459241216UPC 10198459342004UPC 40198459342005UPC 10198459376177UPC 40198459376178UPC 10198459478819UPC 40198459478810UPC 10198459540639UPC 40198459540630UPC 10198459552809UPC 40198459552800Would you have heard about this one?
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