Z-2941-2026Class II

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

Name: Z-2941-2026 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and...
Creator: Bd Switzerland Sarl
Published: 2026-06-16
License: https://open.fda.gov/license/

BD Switzerland SARL / initiated 2026-06-16 / Open, Classified / root cause: manufacturing process

FDA source

BD SWITZERLAND SARL began a recall of 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... on 2026-06-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2941-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-16
Posted: 2026-08-13
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.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA 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: [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
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2941-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2941-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-13

Product code FPA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)