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Medline Industries, LP: Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528

Medical DevicesSource: FDA (device) · Date: 2026-03-04

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Reason / hazard
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Recall initiated
2026-01-05
Code info
1) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25BBO366; 2) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25ABI804; 3) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25ABF375; 4) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24JBL155; 5) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24IBG900; 6) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24FBT801; 7) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24FBC584; 8) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24DBB692; 9) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24BBL239; 10) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23KBO692; 11) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23IBT788; 12) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23HBJ026; 13) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23EBK780; 14) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23DBL149; 15) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23CBJ576 Additional Lot as of 3/27/26: 1) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25IBP134
Product quantity
8773 units (594 additional units 3/27/26)
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98319
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