Baxter 15L Cycler Drainage Bag Sterile — Class II medical device recall Z-0194-2016
Terminated recall by Baxter Healthcare Corp., reported 2015-11-11. Leakage from the inlet port of the 15L Cycler Drainage Bags.
| Recall number | Z-0194-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2015-10-06 |
| Classified | 2015-10-30 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-06-27 |
| Countries outside the US | CA |
| Quantity | 19,440 units |
| Reason classes | packaging |
Product
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Reason for recall
Leakage from the inlet port of the 15L Cycler Drainage Bags.
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-0194-2016. 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.