CAPD Solution Transfer Set with Locking Connector — Class II medical device recall Z-2474-2015
Terminated recall by Baxter Healthcare Corp., reported 2015-09-02, distributed nationwide. Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sani
| Recall number | Z-2474-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2013-02-25 |
| Classified | 2015-08-27 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2016-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BB, BM, BR, BS, CA, CL, CO, CW, DO, EC, FR, GB, GT, GY, HK, HN, ID, IN, JM, JP, KY, MX, MY, NI, NZ, PA, PE, SG, SV, TH, TT, TW, UY, VE |
| Quantity | 35,460 units |
| Reason classes | labeling |
Product
CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.
Reason for recall
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
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-2474-2015. 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.