Cardinal Health Presource Packs IV START TRAY I-Intended for IV… — Class II medical device recall Z-1158-2023
Ongoing recall by Cardinal Health 200, LLC, reported 2023-03-01, distributed nationwide. Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap betwee
| Recall number | Z-1158-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2022-11-18 |
| Classified | 2023-02-22 |
| Reported by FDA | 2023-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 36 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10195594381967, 50195594381965 |
| Lot numbers | 706265 |
| Model numbers | 01-5799A |
| Expiration dates | 2024-05-01 |
Product
Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Reason for recall
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
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-1158-2023. 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.