Cardinal Health Presource surgical kits recalled for endotoxin contamination risk
Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.
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 of high-risk surgical devices with potential for endotoxin contamination. Although no illnesses or injuries have been reported and the hazard is theoretical at this time, endotoxin contamination in surgical materials poses significant risk of serious infection to surgical patients.
Plain-English summary
Cardinal Health 200, LLC is recalling multiple Presource Kit models due to a potential for endotoxin contamination in the non-sterile surgical strips and patties included in the kits. Endotoxins are bacterial toxins that can cause serious infections and adverse reactions when introduced into the surgical field during medical procedures.
Approximately 793,785 units have been distributed worldwide, including throughout the United States, Canada, and Saudi Arabia. The recalled kits encompass numerous catalog numbers and lot numbers across various surgical applications including spine procedures, laminectomy, craniotomy, and orthopedic surgery.
No illnesses or injuries have been reported to date. Healthcare providers and facilities in possession of affected Presource Kits should verify their lot and catalog numbers against the FDA recall notice and discontinue use of affected units. Customers should contact Cardinal Health for instructions on product return and replacement.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 793,785
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) CHIP99SP11
- UDI-DI:10195594137595 (each) 50195594137593 (case)
- Lot Number: 5138229
- 2) CHIP99SP12
- UDI-DI:10195594268466 (each) 50195594268464 (case)
- Lot Number: 5324036
- 3) CHIP99SP13
- UDI-DI:10197106271377 (each) 50197106271375 (case)
- Lot Number: 6907769
- 4) CHIP99SP1E
- UDI-DI:10888439373226 (each) 50888439373224 (case)
- Lot Number: 7045815
- 5) CHIP99SP1E
- Lot Number: 7280043
- 6) CHIP99SP1E
- Lot Number: 6701891
- 7) CHIP99SP1E
- Lot Number: 6701938
- 8) CHIP99SP1E
- Lot Number: 6986974
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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