Custom Healthcare Systems — Class II medical device recall Z-0863-2020
Terminated recall by Custom Healthcare Systems, Inc., reported 2020-02-05, distributed in IL. A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case
| Recall number | Z-0863-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Healthcare Systems, Inc., Richmond, VA, United States |
| Recall initiated | 2019-12-20 |
| Classified | 2020-01-24 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2022-08-01 |
| Distributed | IL |
| Quantity | 240 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00811870033261 |
| Lot numbers | 20190614 |
| Expiration dates | 2020-02-01 |
Product
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Reason for recall
A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained 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-0863-2020. 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.