Bd Switzerland Sarl: Set, Administration, Intravascular
Recall Summary Baxter is recalling certain intravascular administration sets because they may contain air bubbles in the drip chamber and tubing that could allow air to be delivered into a patient's IV line. The affected products are Baxter-brand IV administration sets. This recall applies to patients who have received or may receive treatment using these administration sets.
- Recalling firm
- 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 The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The lntravascular Administration Set and Extension Set may incorporate componentry that aid in the prevention of accidental needle sticks.
- Reason
- Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-16
- Status
- Open, Classified
- Areas affected
- AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MS, ...
- 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
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8dc4b5fc-86dc-4ab1-b333-cce15e87742f