The Recall Desk
HighFDA (Devices)·Z-1759-2022·Announced 2022-09-28

BD MaxGuard Extension Set Recalled for Incorrect Expiration Year

CAREFUSION's BD MaxGuard Extension Set is being recalled because product labels incorrectly list expiration year 2027 instead of 2025. Using expired product may compromise integrity, potentially causing leaks and infection risk.

What this means for you

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 recall with theoretical infection and leakage risk from expiration dating error; no reported illnesses or injuries. Risk-of-harm product without confirmed incidents scores as High per rubric.

Plain-English summary

CAREFUSION is recalling BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site (REF: MX9171, Lot 22029674) due to a labeling error. The product labels list an expiration year of 2027, but the correct expiration year is 2025.

If expired product is used, the integrity of the product may be compromised, which could result in potential leaks and infection risk to patients and healthcare workers.

The affected product was distributed to healthcare facilities in multiple U.S. states. Healthcare providers and facilities should verify the correct expiration date and discontinue use of any units that have expired.

The recalled product

Product
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Manufacturer
CAREFUSION
Hazard
  • infection-risk
  • product-leakage
  • labeling-error

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: 10885403237669
  • Lots: 22029674

Distribution

Distributed in 39 states:

  • AL
  • AR
  • AZ
  • CA
  • CO
  • FL
  • GA
  • IA
  • ID
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MD
  • MI
  • MN
  • MO
  • MS
  • NC
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • SC
  • SD
  • TN
  • TX
  • UT
  • VA
  • VT
  • WA
  • WV
  • WY