FDA Device recall Z-0914-2025
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT,…
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT,… by Cardinal Health 200, citing potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0914-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-08 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH8 6 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH9 7 ) KIT, FETAL SURGERY , Catalog Number PB11FSCHR
Reason
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Identifiers
| code_info | Catalog Number PB11FSC10, UDI/DI 10197106452042 (EA)50197106452040 (CS), Lot Number 6928760 ; Catalog Number P…Catalog Number PB11FSC10, UDI/DI 10197106452042 (EA)50197106452040 (CS), Lot Number 6928760 ; Catalog Number PB11FSCH5, UDI/DI 10195594665951 (EA)50195594665959 (CS), Lot Number 5891312 ; Catalog Number PB11FSCH6, UDI/DI 10195594760984 (EA)50195594760982 (CS), Lot Number 6022131 ; Catalog Number PB11FSCH7, UDI/DI 10195594788704 (EA)50195594788702 (CS), Lot Number 6025788 ; Catalog Number PB11FSCH8, UDI/DI 10197106000229 (EA)50197106000227 (CS), Lot Number J6278R ; Catalog Number PB11FSCH9, UDI/DI 10197106404751 (EA)50197106404759 (CS), Lot Number 6788562 ; Catalog Number PB11FSCHR, UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 7280109 ; Catalog Number PB11FSCHR, UDI/DI 10195594890407 (EA)50195594890405 (CS), Lot Number 6487904 ; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0914-2025%22
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