15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler… — Class II medical device recall Z-0080-2015
Terminated recall by Baxter Healthcare Corp, reported 2014-10-22, distributed nationwide. The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drai
| Recall number | Z-0080-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp, Deerfield, IL, United States |
| Recall initiated | 2013-10-17 |
| Classified | 2014-10-16 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2016-01-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, CA, CH, CZ, DE, DK, EC, EE, ES, FI, FR, GB, GR, HU, IE, IT, JO, JP, KR, LU, LV, MT, MY, NL, NO, NZ, OM, PH, PL, PT, QA, RU, SA, SE, SG, SK, TH, TR, ZA |
| Quantity | 3,085,080 |
| Reason classes | packaging |
| 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 and 127 more |
Product
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Reason for recall
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.
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-0080-2015. 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.