CLASS II ONGOING Device recall · Reported 30 Jun 2021 · FDA Enforcement Report
Bd Uf Pen 32gx4mm 100 Nano recalled by Cardinal Health
Cardinal Health is recalling Bd Uf Pen 32gx4mm 100 Nano, distributed nationwide in the US. The recall was initiated on 16 Mar 2021 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-1933-2021
- FDA event ID
- 87787
- Recalling firm
- Cardinal Health, Dublin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Mar 2021
- FDA classified
- 23 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 16 Mar 2021 | Recall initiated by company | |
| 23 Jun 2021 | Classified by FDA | +99 days |
| 30 Jun 2021 | 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
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Product as listed by the FDA
BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
Where it was distributed
US Nationwide distribution in the states of FL, GA, SC.
Questions about this recall
Why was it recalled?
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Which lots are affected?
NDC/UPC: 8290320122 All lots numbers shipped from 2/23/201 to 3/10/2021
Where was it sold?
US Nationwide distribution in the states of FL, GA, SC.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 87787This product is part of a recall event; the main page for the event is Optichamber Diamond Spacer With Large Mask recalled by Cardinal Health.
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|---|---|---|---|---|---|
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