Agency classClass IIOur severity:High FDA (Devices)·Z-1757-2022·Announced 2022-09-28

BD MaxGuard Extension Sets Recalled for Mislabeled Expiration Dates

CAREFUSION is recalling 17,250 BD MaxGuard Extension Set units with labels listing incorrect expiration year 2027 instead of 2025. Using expired products could compromise device integrity and create infection risk to patients and healthcare workers.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with risk of infection from potential product integrity compromise due to incorrect expiration date. No hospitalizations or injuries are reported; the hazard is theoretical, placing this at the maximum score for theoretical risks without reported harm.

Plain-English summary

CAREFUSION is recalling BD MaxGuard Extension Set with 2 Needleless Y-Site (REF: MX9059) due to incorrect product labeling. The labels for 17,250 units list expiration year 2027, when the correct expiration year is 2025. Affected lot numbers are 22029431 and 22029432.

Use of expired extension sets may compromise product integrity, potentially resulting in leaks. Compromised product integrity and leaks pose a risk of infection to both patients and healthcare workers.

The recalled units have been distributed to healthcare facilities across multiple U.S. states. Healthcare providers should identify any BD MaxGuard Extension Sets with the affected lot numbers in their inventory and verify the expiration date shown on the product label.

The recalled product

Product: BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
Manufacturer: CAREFUSION
Category: Medical Device — Infusion / IV Access
Hazard: infection-risk
expired-product
integrity-compromise
labeling-error
Affected units: 17,250

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

UDI-DI: 10885403237584
Lots: 22029431
22029432

Distribution

Distributed in 39 states:

Part of a larger recall action

This product is one of 9 recalled by CAREFUSION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · CAREFUSION

See all →

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Same hazard · infection risk