BD SWITZERLAND SARL 60 In Non-DEHP Minibore Extension Set RES ME2010 Recall (Month Year)
BD SWITZERLAND SARL is recalling several IV administration sets including the 60 In Non-DEHP Minibore Extension Set RES ME2010, MaxPlus Ext Set with Needleless and Y-Site MPX5305-C, the 9 In Extension Set with Max Y MPX5300-C, and related intravascular administration sets due to potentially inadequate sterilization. About 93,700 units were distributed in the United States (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) and in Canada. FDA recall numbers: RES ME2010 Lot 26025260; MPX5305-C Lot 26035455; MPX5300-C Lot 26055528.
| Brand | BD SWITZERLAND SARL |
|---|---|
| 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. |
| Reason | Products may not have received adequate sterilization processing. |
| Severity | moderate |
| Units affected | 93700 |
| 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 |
| Agency | FDA |
| Recall / campaign no. | 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 |
WHAT YOU SHOULD DO
- Stop using the recalled devices immediately if you have them and contact your healthcare provider or supplier to arrange a replacement or return.
- Check whether your device is affected by comparing its lot number (26025260 for RES ME2010; 26035455 for MPX5305-C; 26055528 for MPX5300-C) or UDI-DI as listed in the recall.
- Do not discard the product until advised; follow instructions from your healthcare provider or supplier for safe disposal or return.
- If you experience any health issues or adverse reactions, seek medical care and report the event to your healthcare provider and FDA MedWatch.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.