Z-1433-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2026
- Initiation Date
- January 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10550 units
Product Description
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Code Information
1) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25JBG340; 2) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25EBV829; 3) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25CBM029; 4) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25BBI797; 5) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25ABW687; 6) DYKM2013, UDI-DI: 10193489796582(each), 40193489796583(case), Lot Number: 23EBN045; 7) DYKM2013, UDI-DI: 10193489796582(each), 40193489796583(case), Lot Number: 23DBM064; 8) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25HBB845; 9) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25GBS259; 10) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25DBR145; 11) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25BBS769; 12) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24KBJ466; 13) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24JBQ815; 14) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24IBU526; 15) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23IBJ540; 16) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23HBP844; 17) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23HBE308; 18) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23GBT102; 19) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 25DLA344; 20) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 25CLA657; 21) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 24GLB208; 22) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 24ELA332; 23) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBS451; 24) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBS450; 25) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBE908; 26) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBE909; 27) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25GBM037; 28) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25GBK565; 29) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25FBL177; 30) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25EBP727; 31) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25EBO749; 32) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBQ021; 33) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBD942; 34) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBA345; 35) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25BBU730; 36) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25BBS503; 37) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25ABM247; 38) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24KBN725; 39) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24KBE264; 40) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH956; 41) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH955; 42) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH957; 43) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24HBQ854; 44) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24HBO200; 45) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24GBN624; 46) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBH929; 47) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBG790; 48) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBD096; 49) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24DBS507; 50) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24DBC075; 51) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24CBG460; 52) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24ABO402; 53) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23LBU172; 54) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23KBK857; 55) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23KBJ794; 56) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23JBM608; 57) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23IBQ747; 58) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23IBO843; 59) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23IBO844; 60) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23HBT781; 61) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23FBK991; 62) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23FBC676; 63) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23EBG472; 64) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23CBW700; 65) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23CBM546