CLASS III ONGOING Device recall · Reported 2 Mar 2022 · FDA Enforcement Report
BD Vacutainer Luer Lok Access Device recalled by Becton Dickinson &
Becton Dickinson & is recalling BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed, distributed nationwide in the US. The recall was initiated on 6 Jan 2022 and the FDA has classified it as Class III.
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-0665-2022
- FDA event ID
- 89486
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 6 Jan 2022
- FDA classified
- 23 Feb 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 6 Jan 2022 | Recall initiated by company | |
| 23 Feb 2022 | Classified by FDA | +48 days |
| 2 Mar 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
Product as listed by the FDA
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200
Where it was distributed
US Nationwide distribution in the state of IL.
Questions about this recall
Is BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed recalled?
Yes. Becton Dickinson & recalled BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed on 6 Jan 2022. The recall is Class III and its status is Ongoing. Recall number Z-0665-2022.
Why was it recalled?
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
Which lots are affected?
All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022
Where was it sold?
US Nationwide distribution in the state of IL.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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