CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report
Monoject 201 Vet Pak Hypodermic Needle-1/2 recalled
Cardinal Health 200 is recalling Monoject 201 Vet Pak Hypodermic Needle-1/2, distributed nationwide in the US. The recall was initiated on 30 Apr 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-2045-2019
- FDA event ID
- 82927
- Recalling firm
- Cardinal Health 200, Mansfield, MA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 30 Apr 2019
- FDA classified
- 23 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 30 Apr 2019 | Recall initiated by company | |
| 23 Jul 2019 | Classified by FDA | +84 days |
| 31 Jul 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
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
Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
Where it was distributed
Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
Questions about this recall
Why was it recalled?
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Which lots are affected?
Lot Number: 905662
Where was it sold?
Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
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
16 other products · FDA event 82927This product is part of a recall event; the main page for the event is Monoject Standard Hypodermic Needle-1/2" bulk recalled.
More recalls from Cardinal Health 200
All 283| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| 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 |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |