FDA Device recall Z-0722-2019
Medline Prefilled 550 ml Sterile¿¿ ¿
- FDA Device
- Class I
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class I recall of Medline Prefilled 550 ml Sterile¿¿ ¿ 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-0722-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-09-05 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medex Cardio Pulmonary D B A Smiths Medical |
| Distribution | US |
Product
Medline Prefilled 550 ml Sterile¿¿ ¿
Reason
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Identifiers
| code_info | Model # HCS00550 Lot Numbers: ¿A092, B205, B534, and Z205 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0722-2019%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.