Monoject 0 — Class I medical device recall Z-2284-2021
Ongoing recall by Cardinal Health, reported 2021-09-01, distributed nationwide. Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syrin
| Recall number | Z-2284-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health, Mansfield, MA, United States |
| Recall initiated | 2021-08-04 |
| Classified | 2021-08-21 |
| Reported by FDA | 2021-09-01 |
| Distributed | Nationwide (US) |
| Quantity | 267,217,860 eaches |
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Reason for recall
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2284-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.