FDA Device recall Z-1157-2023
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
- FDA Device
- Class II
- ongoing
- Published 2023-03-01
On 2023-03-01 the FDA classified a Class II recall of Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B by Cardinal Health 200, citing 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 leak….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1157-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-18 |
| Published | 2023-03-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
Reason
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
Identifiers
| code_info | UDI-DI: 50195594577153(cs) 10195594577155(ea) Lot Number: 816643 Exp. Date: 2/1/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1157-2023%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.