Agency classClass IIOur severity:High FDA (Devices)·Z-1758-2022·Announced 2022-09-28

BD MaxGuard Extension Set Wrong Expiration Label Poses Infection Risk

CAREFUSION is recalling 600 BD MaxGuard Extension Sets because labels list expiration year 2027 instead of 2025. Using expired products may cause leaks and infection risk.

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: This is a Class II FDA recall for a medical device with potential for patient harm through infection risk if expired products are used. No illnesses or injuries have been reported. Per the severity rubric, this constitutes a 'High' (3) severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

CAREFUSION has recalled 600 units of the BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site (REF: MX9166, Lot 22029648). The affected product labels incorrectly list the expiration year as 2027 when it should list 2025.

If expired products are used in clinical settings, the integrity of the administration set may be compromised. This could result in potential leaks that pose a risk of infection to both patients and healthcare workers.

The recalled units were distributed across multiple U.S. states. Healthcare facilities that have received this product should check for the affected lot number and verify the correct expiration date. Facilities should cease use of any units with the incorrect labeling and contact CAREFUSION for replacement or return information.

The recalled product

Product: BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
Manufacturer: CAREFUSION
Category: Medical Device — Administration/Extension Set
Hazard: mis-labeling
infection-risk
leakage
Affected units: 600

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 (2)

UDI-DI: 10885403237652
Lots: 22029648

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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BD MaxGuard Extension Set Recalled for Incorrect Expiration Year
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High
BD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels
FDA (Devices) · 2022-09-28
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BD MaxGuard Administration Set Recalled for Incorrect Expiration Labeling
FDA (Devices) · 2022-09-28
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BD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates
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Same hazard · mis labeling