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Parker Quality & Compliance

PQC Reg Watch

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Device recall

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.

FDA recall source

Recall number
Z-2941-2026
Event id
99264
Status
Ongoing
FDA classification
Class II
Recalling firm
BD SWITZERLAND SARL
Report date
Aug 19, 2026
Initiated
Jun 16, 2026
Center classification date
Aug 13, 2026
Reason
Products may not have received adequate sterilization processing.
Quantity
93,700
Code info
60 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: 26035455 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Lot Number: 26055528
Distribution
U.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
Voluntary or mandated
Voluntary: Firm initiated
Location
Eysins, Switzerland