FDA Device recall Z-0898-2022
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Content…
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Content… by Medline Industries Northfield, citing sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0898-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-04 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
Reason
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
Identifiers
| code_info | Lot #3139133, Exp. 11/01/2022. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0898-2022%22
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