Moderate riskFDA DeviceClass II

BD extension sets recalled over possible inadequate sterilization

BD Switzerland SARL is recalling three intravenous extension and administration set models used to deliver fluids. The products may not have received adequate sterilization. The affected lots were distributed in 26 U.S. states and Canada, about 93,700 units in total, and no injuries have been reported.

From the FDA notice · Read the official notice ↗ · All BD recalls

What to do

  1. Check whether you have the affected models (MPX5305-C, MPX5300-C, ME2010) and the listed lot numbers.
  2. Do not use products from the affected lots.
  3. Contact BD or your supplier for return or replacement information, since the notice does not specify a remedy.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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.
Sold in
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
Made for
All ages (under 100 years)

Details

Units affected
93,700
Illnesses reported
None reported
Manufactured in
Terre Bonne Park A4, Route De Crassier 17, Eysins, Switzerland
Classification
Class II
Recall number
Z-2941-2026

In the FDA's words

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. Products may not have received adequate sterilization processing. 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 Affected quantity: 93,700
Hazard
Products may not have received adequate sterilization processing.

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