FDA Device recall Z-0194-2016
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path by Baxter Healthcare, citing leakage from the inlet port of the 15L Cycler Drainage Bags.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0194-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-06 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Reason
Leakage from the inlet port of the 15L Cycler Drainage Bags.
Identifiers
| code_info | H15C11095 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0194-2016%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.