Z-1757-2022Class II

BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059

Name: Z-1757-2022 BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
Creator: Carefusion
Published: 2022-08-01
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2022-08-01 / Open, Classified / root cause: labeling and UDI

FDA source

CAREFUSION began a recall of BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 on 2022-08-01. FDA classified it as Class II and gives the reason as "Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1757-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-01
Posted: 2022-09-13
Recalling firm: CareFusion 303, Inc
Product: BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
Product code: FPA Set, Administration, Intravascular
Reason for recall: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 8/1/22 Correction-recall notices were emailed or mailed to customers and distributors who were asked to do the following: 1) Destroy affected devices following your institutions process for destruction. 2) Share this notification with all users within your facility network to ensure all are aware. The correction-recall notice should also be shared with any organization where the potentially affected product has been transferred. 3) Complete and return the response form. In addition distributors were informed that the recalling firm plans to notify all affected customers directly so they were asked to provide a a list of customers who received affected devices. The distributor response form has a check box if the distributor declines to provide a customer list to the recalling firm because they have notified customers about the correction-recall. A copy of the customer communication was provided to the distributor. If customers or distributors require additional assistance they are aske to call 1-844-823-5433, Mon-Fri 8:00 AM - 5:00 PM CT or [email protected]
Quantity in commerce: 17,250
Distribution: US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN
Product codes and lots: UDI-DI: 10885403237584, Lots: 22029431, 22029432

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1757-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1752-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-16
Z-1753-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-16
Z-1754-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-16
Z-1755-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-16
Z-1756-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-16
Z-1757-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-16
Z-1758-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-16
Z-1759-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-16
Z-1760-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-16

Product code FPA

K051499Class IIIntravascular Administration Set and Extension SetMedegen Medical Manufacturing Services / cleared 2005-06-22

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)