Agency classClass IIOur severity:High FDA (Devices)·Z-1755-2022·Announced 2022-09-28

BD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates

CAREFUSION is recalling BD MaxGuard Flow Controller Extension Sets because product labels show expiration year 2027 instead of 2025. Using expired sets risks product integrity failure and potential patient infection.

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 an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical: expired product may develop leaks and pose infection risk, but actual harm has not yet been documented. Per the severity rubric, risk-of-harm products without reported injury fall under the High category.

Plain-English summary

CAREFUSION is recalling 37,550 units of the BD MaxGuard Flow Controller Extension Set with Needleless Y-Site (REF: MFS141) distributed across 26 U.S. states. The affected product is identified by UDI-DI 10885403236471 and includes lots 22029167, 22029168, and 22029169.

The product labels list an incorrect expiration year of 2027, when the expiration year should be 2025. This labeling discrepancy creates a significant risk: if expired product is used, the set's integrity may be compromised.

When integrity is compromised, the product may develop leaks and pose a risk of infection to both patients and healthcare workers. No illnesses or injuries have been reported to date.

Healthcare facilities should immediately discontinue use of affected lots and return the product to CAREFUSION. Healthcare providers should verify lot numbers against the recall to ensure affected product is removed from clinical use.

The recalled product

Product: BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Manufacturer: CAREFUSION
Category: Medical Device — Administration Set / Extension Set
Hazard: mis-labeling
product-integrity
infection-risk
Affected units: 37,550

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 (4)

UDI-DI: 10885403236471
Lots: 22029167
22029168
22029169

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 →

High
BD MaxGuard Extension Set Recalled for Incorrect Expiration Year
FDA (Devices) · 2022-09-28
High
BD MaxGuard Extension Set Mislabeled With Wrong Expiration Date
FDA (Devices) · 2022-09-28
High
BD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels
FDA (Devices) · 2022-09-28
High
BD MaxGuard Administration Set Recalled for Incorrect Expiration Labeling
FDA (Devices) · 2022-09-28
High
BD MaxGuard Extension Set Mislabeled with Wrong Expiration Year
FDA (Devices) · 2022-09-28

Same hazard · mis labeling