CLASS II Device recall · Reported 11 Nov 2020 · FDA Enforcement Report
Covidien Monoject Standard Hypodermic Needle, Polypropylene Hub recalled
Cardinal Health 200 is recalling Covidien Monoject Standard Hypodermic Needle, Polypropylene Hub, distributed nationwide in the US. The recall was initiated on 25 Sep 2020 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-0424-2021
- FDA event ID
- 86554
- Recalling firm
- Cardinal Health 200, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2020
- FDA classified
- 5 Nov 2020
- Reported
- 11 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Sep 2020 | Recall initiated by company | |
| 5 Nov 2020 | Classified by FDA | +41 days |
| 11 Nov 2020 | 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
Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle
Product as listed by the FDA
Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code: 8881250248
Where it was distributed
Distribution US Nationwide, Australia and Canada
Questions about this recall
Why was it recalled?
Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle
Which lots are affected?
Lot Number: 011144 Expanded Recall 11/4/20: Lot Number: 011145
Where was it sold?
Distribution US Nationwide, Australia and Canada
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.
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| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
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