Medline Convenience Kits
Medline Convenience Kits contain sterile applicators that may have fungal contamination, potentially causing serious infections.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
From the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the list below, then check the codes the FDA notice also names.
Medline Convenience Kits
- UDI-DI
- 10195327313234
- 40195327313235
- 10198459028915
- 40198459028916
- 10195327215835
- 40195327215836
- 10195327216047
- 40195327216048
- 10195327139957
- 40195327139958
- 10195327113155
- 40195327113156
- Lot
- 24IBA685
- 24IBF913
- 24FBH708
- 24HBG622
- 24GBY827
- 24HBQ593
- 24HBU881
- 24EBI901
- 24HBG834
- 24FBQ907
- 24IBQ580
- 24EBI892
- 24IBE380
- 24EBI893
- 24GBH135
- 24HBG826
- 24EBV834
- 24FBH710
- 24FBK197
- 24GBW340
- 24FBJ622
- 24GBW330
- 24IBJ998
- 24EBC055
- 24FMH509
- 24HBF080
- 24GBO301
- 24HBQ827
- 24HBO219
- UDI-DI
- 10889942508143
- 40889942508144
- 10195327628826
- 40195327628827
- Lot
- 24GMD979
- 24FBM840
- 24HBK903
- UDI-DI
- 10889942424597
- 40889942424598
- 10193489893977
- 40193489893978
- 10195327396268
- 40195327396269
- 10198459043666
- 40198459043667
- 10889942143733
- 40889942143734
- 10889942604722
- 40889942604723
- 10888277797086
- 40888277797087
- Lot
- 24HDA993
- 24IDB285
- 24JDA212
- 24IDB849
- 24HDA071
- 24GDB143
- 24HBS752
- 24FMH385
- 24HBQ828
- UDI-DI
- 10195327574932
- 40195327574933
- 10195327207625
- 40195327207626
- 10884389388679
- 40884389388670
- Lot
- 24FBJ654
- 24FBM444
- 24HBJ581
- 24HBT102
- UDI-DI
- 10889942481293
- 40889942481294
- 10193489277173
- 40193489277174
- Lot
- 24HBS933
- 24HBT600
- UDI-DI
- 10193489848540
- 40193489848541
- Lot
- 24HBH109
- 24HBM182
- 24HBS365
- UDI-DI
- 10889942499953
- 40889942499954
- 10193489484311
- 40193489484312
- Lot
- 24HBF076
- 24HBU638
- 24FMH485
From the FDA notice
1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
Details
- Company began the recall
- Sold in
US Nationwide distribution.
- Event ID
- 99669
- Recall numbers
- Z-3121-2026 to Z-3127-2026
- Company
- Medline Industries, LPNorthfield, Illinois
- Hazard
- Contamination
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
