Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination
Cardinal Health Presource Kits may contain endotoxin-contaminated non-sterile surgical strips and patties. These kits are used in surgical procedures and have been distributed worldwide including the US, Canada, and Saudi Arabia. Affected facilities should verify lot numbers against the recall list.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with potential for endotoxin contamination in surgical materials used during invasive procedures. No illnesses or deaths have been reported. The scenario represents risk-of-harm in high-risk surgical settings, meeting the criterion for High severity.
Plain-English summary
Cardinal Health 200, LLC is recalling Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties included in these kits. These kits are used in surgical procedures including carotid endarterectomy, vascular repairs, and neurovascular procedures.
The recall affects 973,785 units distributed in the United States, Canada, and Saudi Arabia. Multiple product catalog numbers and lot numbers are included in this recall. Specific lot numbers and UDI codes are available through the FDA recall notice and Cardinal Health.
Healthcare facilities and surgical centers should verify whether they have received any of the affected kits by checking the recalled lot numbers. Kits with affected lot numbers should not be used. Contact Cardinal Health for information on handling of recalled materials.
The recalled product
- 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…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 973,785
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) PVV20110B
- UDI-DI:10197106291412 (each) 50197106291410 (case)
- Lot Number: 6788690
- 2) PVV20110B
- Lot Number: 6806122
- 3) PVV20110B
- Lot Number: 7160517
- 4) PVV20110D
- UDI-DI:10197106546505 (each) 50197106546503 (case)
- Lot Number: 7287574
- 5) PVV2CA103
- UDI-DI:10888439714081 (each) 50888439714089 (case)
- Lot Number: J46C12
- 6) PVV2CA10T
- UDI-DI:10888439349467 (each) 50888439349465 (case)
- Lot Number: J46C11
- 7) PVV2CA10T
- Lot Number: J43W16
- 8) PVV2CA10T
- Lot Number: J6022K
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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