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Device Class II · moderate Ongoing

60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fluids.

Products may not have received adequate sterilization processing.

Recalling firmBD SWITZERLAND SARL
ReasonProducts may not have received adequate sterilization processing.
Risk classClass II (Class II · moderate)
StatusOngoing
Report dateAug 19, 2026
InitiatedJun 16, 2026
RegionSwitzerland
DistributionU.S.: AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA O.U.S.: Canada
Quantity93,700
Code/Lot60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 Lot Number: 26025260 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 Lot Number: 2603545…
TypeVoluntary: Firm initiated
Recall numberZ-2941-2026

Official source

U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗

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