BD SWITZERLAND SARL: 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.

Recall number

Z-2941-2026

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.

Status

Open, Classified

Initiated

2026-06-16

Posted

2026-08-13

Terminated

not on file

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.

Root cause

Process control

Action

On 06/16/2026, an "URGENT: Medical Device Recall" Letter was emailed to customers informing them that, BD has identified a mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in product not being sterilized correctly. Customer are instructed to: "Immediately discontinue use of the affected lot(s). "Check all inventory locations within your facility and destroy all affected units in accordance with your facility s process. If destruction is not immediately possible at your facility, then product should be quarantined until disposal. "If product is currently in use, replace with non-impacted product as soon as possible. 1. Provide a copy of this notification to any customers and/or facilities you may have distributed devices to. 2. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 4. Report any complaints experienced with the use of this product to BD via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT Email: productcomplaints@bd.com For: Product Complaints, Technical Questions Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT

Quantity

93,700

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

Lot, serial or model codes

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

510(k) numbers

["K051499","K083472"]

PMA numbers

not on file

Product code

FPA

Firm FEI

3012798826

Firm city

Eysins

Firm state

not on file

Firm country

Switzerland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy