- Recalling firm
- Medline Industries, LP
- 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.
- Affected products (lot / model / serial)
- 1) DYKM2751, UDI-DI: 10198459118395(each), 40198459118396(case), Lot Number: 24LBQ727; 2) DYKM2751, UDI-DI: 10198459118395(each), 40198459118396(case), Lot Number: 24JBB775; 3) DYKM2751A, UDI-DI: 10198459313301(each), 40198459313302(case), Lot Number: 25KMD727; 4) DYKS1583A, UDI-DI: 10198459146640(each), 40198459146641(case), Lot Number: 24KBP388; 5) DYKS1583A, UDI-DI: 10198459146640(each), 40198459146641(case), Lot Number: 24JBA739; 6) DYKS1583B, UDI-DI: 10198459292699(each), 40198459292690(case), Lot Number: 25DBM037
- Units affected
- 2080 kits
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3061-2026
- Recall initiated
- June 12, 2026
- FDA classification date
- August 31, 2026
- FDA report date
- September 9, 2026
- FDA event ID
- 99334
- Last updated on HTM Vibe
- September 15, 2026