60 In Non-DEHP Minibore Extension Set RES ME2010 recallZ-2941-2026 · Bd Switzerland Sarl · initiated Jun 16, 2026

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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: [email protected] 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

Recall details

Recall number

Z-2941-2026

Status

Open, Classified

Initiated by the company

Jun 16, 2026

Posted by the FDA

Aug 13, 2026

Recalling firm

Bd Switzerland Sarl

Quantity

93,700

Product code

FPA

FDA submissions

K051499, K083472

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

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 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.

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

• MaxPlus MPX5300-C

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall33 reports
• MaxGuard ME2010

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall19 reports
• MaxPlus MPX5305-C

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall2 reports

Product lines

• MaxPlusBD Switzerland Sàrl · 18 models · 762 reports · 2 recalls
• MaxGuardBD Switzerland Sàrl · 49 models · 780 reports · 11 recalls