Cardinal Health Maxillofacial Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.
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 classified this as Class II. No illnesses, injuries, or deaths have been reported. However, endotoxin contamination in non-sterile surgical materials represents a risk-of-harm scenario with potential for patient harm, meeting the High (3) severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling Presource maxillofacial surgical kits due to potential endotoxin contamination in the non-sterile surgical strips and patties. The recall involves 973,785 total units across 21 different catalog numbers and 35 lot numbers.
Endotoxins are bacterial contaminants that may be present in non-sterile materials. Their presence in surgical products intended for maxillofacial procedures represents a potential health concern, as surgical use can introduce such contaminants into the body.
The affected products were distributed worldwide to the United States, Canada, and Saudi Arabia. Affected catalog numbers include PWV2MF104, PWV2MF105, PWV2MF106, PWV2MF107, PWV2MF108, PWV2MF109, PWV2MF10V, PWV2MF10W, PWV2MF10Y, PWV2MF10Z, PWV2MF111, PWV2MF112, PWV2MFCP2, PWV2MFCP3, PWV2MFCP4, PWV2MFCPA, PWV2MFCPB, PWV2MFCPC, PWV2MFCPD, PWV2MFCPE, and PWV2MFCPF with corresponding lot numbers identified in the official notice.
Healthcare facilities should immediately quarantine affected products by catalog number and lot number, discontinue use, and contact Cardinal Health for instructions on product return and replacement.
The recalled product
- Product
- Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107…
- 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) PWV2MF104
- UDI-DI:10888439676167 (each) 50888439676165 (case)
- Lot Number: J46C10
- 2) PWV2MF105
- UDI-DI:10195594004217 (each) 50195594004215 (case)
- Lot Number: J8998R
- 3) PWV2MF106
- UDI-DI:10195594095994 (each) 50195594095992 (case)
- Lot Number: 5136000
- 4) PWV2MF107
- UDI-DI:10195594148065 (each) 50195594148063 (case)
- Lot Number: 5140389
- 5) PWV2MF108
- UDI-DI:10195594228941 (each) 50195594228949 (case)
- 6) PWV2MF109
- UDI-DI:10195594394875 (each) 50195594394873 (case)
- Lot Number: J65K18
- 7) PWV2MF10V
- UDI-DI:10888439342741 (each) 50888439342749 (case)
- Lot Number: HP1027
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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