Recall Z-2941-2026— BD SWITZERLAND SARL
Class II · Ongoing
Class II FDA medical device recall by BD SWITZERLAND SARL, initiated 2026-06-16. It names 2 FDA 510(k) clearances: K083472, K051499. 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..
- Recalling firm
- BD SWITZERLAND SARL
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-16
- Firm location
- Eysins, Switzerland
510(k) clearances named in this recall
2 on FDA's record- K083472 — MEDEGEN PRESSURE RATED EXTENSION SETS
- K051499 — INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.