Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling approximately 973,785 Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to healthcare facilities worldwide.
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 endotoxin contamination in sterile surgical instruments. Although no illnesses or injuries have been reported, endotoxin is a high-risk biological hazard that could cause serious infection or inflammatory reactions in surgical applications.
Plain-English summary
Cardinal Health 200, LLC is recalling multiple lots of Presource Kits, surgical instrument packages used in otolaryngology (ENT) and surgical procedures. The recalled products include various nasal septoplasty kits, sinus endoscopy kits, ear surgery kits, and other surgical packages. Approximately 973,785 units were distributed worldwide.
The recall was initiated due to potential endotoxin contamination in non-sterile surgical strips and patties contained within these kits. Endotoxins are bacterial toxins that can cause infection or inflammatory reactions if exposed to sterile surgical sites during procedures.
The affected kits were distributed to healthcare facilities across the United States, Canada, and Saudi Arabia. Multiple product catalog numbers and lot numbers are included in this recall.
Healthcare providers who have received these Presource Kits should contact their supplier. Details about specific affected products and lot numbers are available through the FDA.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 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) PE29NSFG4
- UDI-DI:10195594302870 (each) 50195594302878 (case)
- Lot Number: 5140385
- 2) PE29NSFG5
- UDI-DI:10195594429980 (each) 50195594429988 (case)
- Lot Number: 5478805
- 3) PE29NSFG6
- UDI-DI:10195594510046 (each) 50195594510044 (case)
- Lot Number: 5664108
- 4) PE29NSFG7
- UDI-DI:10197106511206 (each) 50197106511204 (case)
- Lot Number: 7280115
- 5) PE29NSFG8
- UDI-DI:10197106535981 (each) 50197106535989 (case)
- Lot Number: 7320240
- 6) PE29NSFGM
- UDI-DI:10885425554638 (each) 50885425554636 (case)
- Lot Number: J3593N
- 7) PE29NSFGM
- Lot Number: J46C07
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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