CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report
BD Microtainer Z (No Additive Tubes) Part recalled by Becton Dickinson &
Becton Dickinson & is recalling BD Microtainer Z (No Additive Tubes) Part, distributed nationwide in the US. The recall was initiated on 13 May 2019 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-0054-2020
- FDA event ID
- 82851
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2019
- FDA classified
- 7 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 13 May 2019 | Recall initiated by company | |
| 7 Oct 2019 | Classified by FDA | +147 days |
| 16 Oct 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
Where it was distributed
Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Questions about this recall
Is BD Microtainer Z (No Additive Tubes) Part recalled?
Yes. Becton Dickinson & recalled BD Microtainer Z (No Additive Tubes) Part on 13 May 2019. The recall is Class II and its status is Terminated. Recall number Z-0054-2020.
Why was it recalled?
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Which lots are affected?
Lot Number/UDI: 8117750 (01)30382903659631 (17)191031(10)8117750(30)50 (17)191031(10)8117750(30)200 (01)50382903659635 8155792 (01)30382903659631 (17)191130(10)8155792(30)50 (17)191130(10)8155792(30)200 (01)50382903659635 8223778 (01)30382903659631 (17)200131(10)8223778(30)50 (17)200131(10)8223778(30)200 (01)50382903659635 8223779 (01)30382903659631 (17)200131(10)8223779(30)50 (17)200131(10)8223779(30)200 (01)50382903659635 8268514 (01)30382903659631 (17)200229(10)8268514(30)50 (17)200229(10)8268514(30)200 (01)50382903659635
Where was it sold?
Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
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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