FDA Device recall Z-0080-2015
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory
- FDA Device
- Class II
- terminated
- Published 2014-10-22
On 2014-10-22 the FDA classified a Class II recall of 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory by Baxter Healthcare, citing the large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0080-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-17 |
| Published | 2014-10-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Reason
The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.
Identifiers
| code_info | Lot numbers: H12K20044, H12K20085, H12K21026, H13B04052, H13B04086, H13B05042, H13B05067, H13B06073, H13B07063, H13B130…Lot numbers: H12K20044, H12K20085, H12K21026, H13B04052, H13B04086, H13B05042, H13B05067, H13B06073, H13B07063, H13B13087, H13B14069, H13B14085, H13B15066, H13B18029, H13B18084, H13B20108, H13B22013, H13B22062, H13B23060, H13B24043, H13B25032, H13B25107, H13C06030, H13C06055, H13C07053, H13C07087, H13C08051, H13C09026, H13C09034, H13C09075, H13C11089, H13C12046, H13C12061, H13C13069, H13C19124, H13C20031, H13C20106, H13C21054, H13C22029, H13C25048, H13C25071, H13C26038, H13C26137, H13D02086, H13D03068, H13D04033, H13D04108, H13D10089, H13D10097, H13D11087, H13D12051, H13D12101, H13D13034, H13D13067, H13D15070, H13D15112, H13D16078, H13D16110, H13D19056, H13D19098, H13D20013, H13D20062, H13D21029, H13D22043, H13D22084, H13D23025, H13D23041, H13D24064, H13D25020, H13D25095, H13E01036, H13E01077, H13E02026, H13E02091, H13E03016, H13E07116, H13E08023, H13E08049, H13E09070, H13E10011, H13E10029, H13E13015, H13E13031, H13E14088, H13E14104, H13E15036, H13E21083, H13E22073, H13E23022, H13E2305 |
|---|
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-0080-2015%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.