CLASS II ONGOING Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
BD Connecta" Plus3 White Blend OEM (sterile, bulk) recalled
Becton Dickinson & is recalling BD Connecta" Plus3 White Blend OEM (sterile, bulk), distributed nationwide in the US. The recall was initiated on 9 May 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-1439-2022
- FDA event ID
- 90304
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 May 2022
- FDA classified
- 21 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 9 May 2022 | Recall initiated by company | |
| 21 Jul 2022 | Classified by FDA | +73 days |
| 27 Jul 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.
Nationwide AlaskaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIllinoisIndianaKansasMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNebraskaNew JerseyNevada
Questions about this recall
Is BD Connecta" Plus3 White Blend OEM (sterile, bulk) recalled?
Yes. Becton Dickinson & recalled BD Connecta" Plus3 White Blend OEM (sterile, bulk) on 9 May 2022. The recall is Class II and its status is Ongoing. Recall number Z-1439-2022.
Why was it recalled?
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.
Which lots are affected?
GTIN: N/A Lot Numbers/Exp.Date: 1127328
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.
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.
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