60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF

FDA device recall Z-2941-2026 · posted 2026-08-13 · Open, Classified

Recall details

Recalling firm

BD SWITZERLAND SARL

Reason for recall

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.

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

FPA

Quantity affected

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

Date initiated

2026-06-16

Date posted

2026-08-13

Location

Eysins, Switzerland

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