Z-2941-2026 Class II Ongoing
FDA device recall Z-2941-2026 was initiated by BD SWITZERLAND SARL on June 16, 2026 and is designated Class II. Reason for recall: Products may not have received adequate sterilization processing. The recall status is ongoing. Affected quantity: 93,700.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2026
- Initiation Date
- June 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93,700
Product Description
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.
Reason for Recall
Products may not have received adequate sterilization processing.
Distribution Pattern
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
Code Information
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