Monoject 100 Units/mL Heparin Lock Flush — Class II medical device recall Z-2185-2013
Terminated recall by Covidien LLC, reported 2013-09-18, distributed nationwide. Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
| Recall number | Z-2185-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, Mansfield, MA, United States |
| Recall initiated | 2013-08-16 |
| Classified | 2013-09-10 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2015-10-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM |
| Reason classes | labeling, sterility |
| Lot numbers | 13A0084N |
Product
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices
Reason for recall
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
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-2185-2013. 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.