0 — Class II medical device recall Z-2476-2015
Terminated recall by MRP, LLC dba AMUSA, reported 2015-09-02, distributed in CA, FL, MA, MD, PA, TN, TX, UT…. Procedures for the acceptance and control of in-process product have not been adequately established.
| Recall number | Z-2476-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MRP, LLC dba AMUSA, Nashville, TN, United States |
| Recall initiated | 2015-07-02 |
| Classified | 2015-08-27 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2017-04-03 |
| Distributed | CA, FL, MA, MD, PA, TN, TX, UT, VA, WV |
| Quantity | 551 cases |
| Expiration dates | 2016-07, 2016-08, 2016-11, 2016-12 |
Product
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Reason for recall
Procedures for the acceptance and control of in-process product have not been adequately established.
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-2476-2015. 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.