FDA Device recall Z-1661-2015
Direct Water feed Kit, Catalog#10373222
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of Direct Water feed Kit, Catalog#10373222 by Siemens Medical Solutions Diagnostics, citing the bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid W….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1661-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-05 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Diagnostics |
| Distribution | n/a |
Product
Direct Water feed Kit, Catalog#10373222
Reason
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Identifiers
| code_info | Direct Water Feed Kit - Product Code/Catalog #10373222 |
|---|
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-1661-2015%22
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