Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 973,785 units were distributed to the US, Canada, and Saudi Arabia.
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 with potential endotoxin contamination in surgical materials. The source describes this as a potential rather than confirmed finding with no illnesses or injuries reported, meeting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health is recalling multiple Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties included in these products. The affected kits include DIEP Flap kits, Head and Neck surgical kits, Free Flap Head kits, Williams Spine kits, and additional surgical kits with specified catalog and lot numbers. Approximately 973,785 units were distributed worldwide to the United States, Canada, and Saudi Arabia.
Endotoxins are bacterial contaminants that can present a risk in surgical applications where sterility is required. The source identifies this as a potential contamination issue rather than a confirmed finding at this time.
Affected healthcare facilities and surgical centers should refer to the FDA recall notice for detailed information about the specific product lot numbers and catalog numbers involved, and should contact Cardinal Health or their distributor for instructions regarding product return, replacement, or disposal.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5)…
- 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) PB23DFCM3
- UDI-DI:10888439587050 (each) 50888439587058 (case)
- Lot Number: J37U13
- 2) PB23DFCM4
- UDI-DI:10888439601053 (each) 50888439601051 (case)
- Lot Number: J37U14
- 3) PB23DFCM5
- UDI-DI:10888439641790 (each) 50888439641798 (case)
- Lot Number: J46C08
- 4) PB23DFCM6
- UDI-DI:10888439836172 (each) 50888439836170 (case)
- Lot Number: J6050A
- 5) PB23DFCM7
- UDI-DI:10888439853087 (each) 50888439853085 (case)
- Lot Number: J7704J
- 6) PB23DFCMA
- UDI-DI:10887488531298 (each) 50887488531296 (case)
- Lot Number: J4952P
- 7) PB23DFCMA
- Lot Number: J53W77
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.
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