Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling Presource Kits (surgical strips and patties used in ophthalmic procedures) due to potential endotoxin contamination in non-sterile components.
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: This FDA Class II medical device recall involves potential endotoxin contamination in surgical kits used in sterile ophthalmic procedures. The hazard is characterized as 'potential' rather than confirmed, and no illnesses or injuries have been reported. Under the severity rubric, this qualifies as High (Score 3) as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Presource Kit products used in ophthalmic (eye) surgical procedures. The affected products include Ophthalmology Endo DCR Extraction Packs and Ocular Plastic Packs, with approximately 973,785 units involved. These kits were distributed worldwide, including to the United States, Canada, and Saudi Arabia.
The recall is due to potential endotoxin contamination in the non-sterile surgical strips and patties included in the kits. Endotoxin is a bacterial toxin that can cause pyrogenic reactions and potentially serious complications if introduced into the surgical field.
Specific affected catalog numbers and lot numbers have been identified in the FDA recall notice and are available from the manufacturer.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5)…
- Manufacturer
- Cardinal Health 200, LLC
- 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) SEY30EYRVA
- UDI-DI:10195594159382 (each) 50195594159380 (case)
- Lot Number: 5140378
- 2) SEY30EYRVB
- UDI-DI:10195594555771 (each) 50195594555779 (case)
- Lot Number: 5970335
- 3) SEY30EYRVB
- Lot Number: 6133661
- 4) SEY30EYRVC
- UDI-DI:10195594759735 (each) 50195594759733 (case)
- Lot Number: 6701854
- 5) SEY30EYRVC
- Lot Number: 6702035
- 6) SEY30EYRVC
- Lot Number: 7266056
- 7) SEY30EYRVC
- Lot Number: 7280113
- 8) SEY30EYRVC
- Lot Number: 7280116
- 9) SEY30EYRVC
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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