CLASS II ONGOING Device recall · Reported 28 Sep 2022 · FDA Enforcement Report
BD MaxGuard Extension Set with 2 Micron Filter and Needleless Y-Site recalled
Carefusion is recalling BD MaxGuard Extension Set with 2 Micron Filter and Needleless Y-Site, distributed in 39 states. The recall was initiated on 1 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1759-2022
- FDA event ID
- 90707
- Recalling firm
- Carefusion, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Aug 2022
- FDA classified
- 16 Sep 2022
- Reported
- 28 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 1 Aug 2022 | Recall initiated by company | |
| 16 Sep 2022 | Classified by FDA | +46 days |
| 28 Sep 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Where it was distributed
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
AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippi
Questions about this recall
Is BD MaxGuard Extension Set with 2 Micron Filter and Needleless Y-Site recalled?
Yes. Carefusion recalled BD MaxGuard Extension Set with 2 Micron Filter and Needleless Y-Site on 1 Aug 2022. The recall is Class II and its status is Ongoing. Recall number Z-1759-2022.
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 10885403237669, Lots: 22029674
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Carefusion
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BD MaxGuard Extension Set recalled by Carefusion | Carefusion | Packaging Defects | 39 states |
| Device | CLASS II | BD MaxGuard Extension Set with 4-way stopcock recalled by Carefusion | Carefusion | Packaging Defects | 39 states |
| Device | CLASS II | BD MaxGuard Extension Set with 2 Needleless Y-Site recalled | Carefusion | Packaging Defects | 39 states |
| Device | CLASS II | BD MaxGuard Extension Set with 2 Micron Filter and Needleless Y-Site recalled | Carefusion | Packaging Defects | 39 states |
| Device | CLASS II | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site recalled | Carefusion | Packaging Defects | 39 states |
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|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | Bd Switzerland Sarl | Other | IL |