Cardinal Health Presource Aneurysm Packs recalled for potential endotoxin contamination
Cardinal Health Presource surgical kits used in aneurysm procedures may contain endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units distributed worldwide; no illnesses reported.
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 medical device recall involving potential high-risk bacterial contamination. No illnesses or injuries have been reported. This fits the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' yielding a score of 3 (High).
Plain-English summary
Cardinal Health 200, LLC is recalling Presource Kits containing aneurysm packs due to potential endotoxin contamination in non-sterile surgical strips and patties. The affected catalog numbers are SCVHFAPBM1, SCVHFAPBM3, SCVHFAPBM5, SCVHFAPBM6, and SCVHFAPBM7. Approximately 512,786 units have been distributed worldwide, including throughout the United States, Canada, and Saudi Arabia.
Endotoxin is a bacterial substance that can cause infection if it enters the bloodstream or surgical field. The presence of potential endotoxin contamination in these surgical kits poses a risk of post-operative infection during vascular procedures.
The FDA has classified this recall as Class II. Healthcare facilities that have received these products should contact the recalling manufacturer for information regarding affected lot numbers and next steps.
The recalled product
- Product
- Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM6; 5 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM7
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 512,786
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)
- Catalog Number SCVHFAPBM1
- UDI/DI 10888439782530 (EA)50888439782538 (CS)
- Lot Number J5678Z
- Lot Number N/A
- Lot Number J6049R
- Lot Number J53W78
- Catalog Number SCVHFAPBM3
- UDI/DI 10888439834239 (EA)50888439834237 (CS)
- Lot Number J74A27
- Lot Number J7412G
- Lot Number J6050A
- Catalog Number SCVHFAPBM5
- UDI/DI 10888439931624 (EA)50888439931622 (CS)
- Lot Number J8124C
- Lot Number J8393C
- Lot Number J7905J
- Catalog Number SCVHFAPBM6
- UDI/DI 10195594031701 (EA)50195594031709 (CS)
- Lot Number J6367G
- Lot Number J9602R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
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