Cardinal Health Presource Kits: 1) KIT — Class II medical device recall Z-1129-2025
Ongoing recall by Cardinal Health 200, LLC, reported 2025-02-19, distributed nationwide. Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
| Recall number | Z-1129-2025 |
|---|---|
| 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 | 2024-11-08 |
| Classified | 2025-02-10 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SA |
| Quantity | 973,785 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10195594091989, 10195594154073, 10195594175795, 10195594243616, 10195594324940, 10195594381400, 10195594450007, 10195594616182, 10197106067062, 10197106231142, 10197106232293, 10197106291412, 10197106514481, 10197106546505, 10888439248883, 10888439349467, 10888439693607, 10888439714081, 10888439785494, 10888439928877, 10888439967265, 50195594091987, 50195594154071, 50195594175793, 50195594243614 and 17 more |
| Lot numbers | 5138326, 5138335, 5140389, 5405620, 5664115, 5775803, 5858468, 5858469, 6022069, 6116189, 6133658, 6232003, 6251075, 6345513, 6416679, 6470289, 6560950, 6568688, 6701998, 6702001, 6748352, 6775065, 6775068, 6788690, 6806122, 7005463, 7005466, 7055826, 7160517, 7280092, 7280093, 7287469, 7287574, 7331456, 7332825, 7332855, 7332861, D212939, J3986T, J4219R and 19 more |
| Model numbers | PVV20110B, PVV20110D, PVV2CA103, PVV2CA10T, PVV2CA10U, PVV2CA10X, PVV2CA10Y, SCV13AASLA, SCV30VAF10, SCV30VAFH4, SCV30VAFH5, SCV30VAFH6, SCV30VAFH7, SCV30VAFH8, SCV30VAFH9, SCV30VAFHP, SCV30VAFHQ, SCV30VAFHR, SCV30VAFHS, SNE11AN102, SNE11AN10E |
Product
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10U 6) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10X 7) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10Y 8) SLH AAA PACK, Catalog Number:SCV13AASLA 9) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAF10 10) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH4 11) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH5 12) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH6 13) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH7 14) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH8 15) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH9 16) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHP 17) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHQ 18) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHR 19) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHS 20) NEURO EMBOLISM PACK, Catalog Number:SNE11AN102 21) NEURO EMBOLISM PACK, Catalog Number:SNE11AN10E
Reason for recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
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-1129-2025. 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.