Cardinal Health Presource 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. The recall affects 512,786 units distributed 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 recall due to potential endotoxin contamination in surgical materials. No illnesses or injuries have been reported. Per the severity rubric, potential hazards without confirmed reports of harm are rated at score 3.
Plain-English summary
Cardinal Health Presource surgical kits are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties in the kits. The recall includes orthoplastic microvascular, spine, laminectomy, and anterior cervical surgical kits, with multiple specific catalog numbers and lot numbers affected.
A total of 512,786 units are involved in the recall. These kits have been distributed worldwide, including in the United States, Canada, and Saudi Arabia. Healthcare facilities and surgical professionals should verify their inventory of Cardinal Health Presource kits against the specific lot and catalog numbers listed in the official FDA recall notice.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- 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 PGVMFFBLY
- UDI/DI 10888439011371 (EA)50888439011379 (CS)
- Lot Number J34J41
- Lot Number J43U77
- Catalog Number PGVMFFBLZ
- UDI/DI 10888439641936 (EA)50888439641934 (CS)
- Lot Number J4952G
- Lot Number J53W73
- Lot Number J4952H
- Lot Number J6050F
- Lot Number J74A27
- Lot Number J7963D
- Lot Number J7905F
- Lot Number J84K02
- Lot Number J8692Y
- Lot Number J86T82
- Catalog Number PN23SPAM5
- UDI/DI 10195594235604 (EA)50195594235602 (CS)
- Lot Number 20166041-3014
- Lot Number 5138318
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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