Z-3056-2026 Class II Ongoing

Recalled by Medline Industries, LP — Northfield, IL

FDA device recall Z-3056-2026 was initiated by Medline Industries, LP on June 12, 2026 and is designated Class II. Reason for recall: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the… The recall status is ongoing. Affected quantity: 22736 Kits.

Recall Details

Product Type
Devices
Report Date
September 9, 2026
Initiation Date
June 12, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22736 Kits

Product Description

Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Model Number: DYKM2187A; 5) IV BLOOD CULTURE KIT, Model Number: DYNDH1909A; 6) IV START W/EXT SET KIT, Model Number: DYNDV1615I

Reason for Recall

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

Distribution Pattern

US Nationwide distribution.

Code Information

1) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 25DBN710; 2) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24BBH722; 3) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24CBV460; 4) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24EBR549; 5) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24GBH769; 6) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 23KBN939; 7) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 23LBT913; 8) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24AMB256; 9) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24BMF851; 10) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24DMC055; 11) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24FMB552; 12) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24IMF355; 13) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24KMD782; 14) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 23IMI364; 15) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 23JMG372; 16) DYKM2187, UDI-DI: 10195327232924(each), 40195327232925(case), Lot Number: 23JBQ286; 17) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 25ABI946; 18) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 25ABV328; 19) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24LBM058; 20) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24LBO554; 21) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24CBB880; 22) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24CBT739; 23) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24CBV226; 24) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24IBL537; 25) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24JBL006; 26) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25KME690; 27) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25AMI449; 28) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25BMB196; 29) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25BMI538; 30) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 24JMG337; 31) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 24KMH747; 32) DYNDV1615I, UDI-DI: 10195327407100(each), 40195327407101(case), Lot Number: 24DBM033