FDA Device recall Z-0490-2019
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
- FDA Device
- Class II
- terminated
- Published 2018-11-28
On 2018-11-28 the FDA classified a Class II recall of Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 by Medex Cardio Pulmonary D B A Smiths Medical, citing lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0490-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-05 |
| Published | 2018-11-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medex Cardio Pulmonary D B A Smiths Medical |
| Distribution | AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI |
Product
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Reason
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Identifiers
| code_info | Model # FB-A-400-107 Lot Number: 4J006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0490-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.