Cardinal Health Fetal Surgery Kits Recalled for Endotoxin Contamination Risk
Cardinal Health is recalling Presource fetal surgery kits due to potential endotoxin contamination in non-sterile surgical strips and patties, which could pose infection risk.
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 without reported illnesses or injuries. The hazard is potential rather than confirmed, so severity is capped at High per the rubric.
Plain-English summary
Cardinal Health 200, LLC is recalling multiple Presource surgical kit models used for fetal surgery procedures. Approximately 512,786 units have been distributed worldwide, including the United States, Canada, and Saudi Arabia. The recalled kits are identified by catalog numbers PB11FSC10, PB11FSCH5, PB11FSCH6, PB11FSCH7, PB11FSCH8, PB11FSCH9, and PB11FSCHR.
The kits are being recalled due to potential endotoxin contamination in the non-sterile surgical strips and patties included in the kits. Endotoxin exposure in surgical settings can increase the risk of infection.
Healthcare facilities that have received these kits should discontinue use and contact Cardinal Health for information on replacement products. Patients who have had surgery using these kits should contact their healthcare provider if they experience signs of infection.
The recalled product
- 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…
- Manufacturer
- Cardinal Health 200, LLC
- 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 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)
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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