Monoject Bluntfill with Filter — Class II medical device recall Z-1456-2020
Terminated recall by Cardinal Health 200, LLC, reported 2020-03-18, distributed nationwide. Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ;
| Recall number | Z-1456-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Mansfield, MA, United States |
| Recall initiated | 2020-01-15 |
| Classified | 2020-03-09 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2020-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, DE, ES, GB, IE, PT, ZA |
| Quantity | 8,000 |
| Reason classes | labeling, sterility |
| Lot numbers | 15072024 |
| Model numbers | 11811022F |
| Expiration dates | 2020-06-20 |
Product
Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
Reason for recall
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
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-1456-2020. 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.