CLASS II Device recall · Reported 21 Dec 2022 · FDA Enforcement Report
CarePoint Syringe Without Needle recalled by Allison Medical
Allison Medical is recalling CarePoint Syringe Without Needle, distributed in Florida, Iowa, Louisiana, Mississippi, Puerto Rico. The recall was initiated on 3 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-0478-2023
- FDA event ID
- 91092
- Recalling firm
- Allison Medical, Littleton, CO
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 3 Sep 2020
- FDA classified
- 13 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Syringes & Needles
Timeline
| 3 Sep 2020 | Recall initiated by company | |
| 13 Dec 2022 | Classified by FDA | +831 days |
| 21 Dec 2022 | 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
Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
CarePoint 60 mL Syringe Without Needle, REF: 04-7560
Where it was distributed
US: IA, LA, MS, FL, PR; OUS: BARBADOS
Questions about this recall
Is CarePoint Syringe Without Needle recalled?
Yes. Allison Medical recalled CarePoint Syringe Without Needle on 3 Sep 2020. The recall is Class II and its status is Completed. Recall number Z-0478-2023.
Why was it recalled?
Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.
Which lots are affected?
UDI-DI: 00786227756059, REF/Lot: 04-7560/ 80522
Where was it sold?
US: IA, LA, MS, FL, PR; OUS: BARBADOS
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.
More recalls from Allison Medical
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|---|---|---|---|---|---|
| Device | CLASS II | InControl Insulin Syringes, Short Needle, 1CC recalled | Allison Medical | Labeling Errors | TX |
Other Syringes & Needles recalls
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|---|---|---|---|---|---|
| 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 |