Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH recall: Sterility Concern
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…
Why was Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Medline Industries, LP
- Quantity
- 22736 Kits
- Distribution
- US Nationwide distribution.
- Recall date
- September 9, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)