Cook Inc. Recalls VentriClear Ventricular Drainage Catheter Sets Due to Endotoxin Failure
Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set because the product failed endotoxin testing. The recall involves one distributor in Indiana, and the product was not distributed to end users.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The source text explicitly identifies the potential for 'life-threatening systemic inflammatory response syndrome (SIRS),' which aligns with the rubric criteria for Severe (4) involving significant injury reports or high-risk theoretical harm for medical devices.
Plain-English summary
Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set, Catalog Number N-VVDC-01-ABRM, Lot 8639185. The recall was initiated because the specific lot of the device failed endotoxin testing.
The VentriClear Ventricular Drainage Catheter Set is a medical device designed for short-term use to obtain access to a ventricular cavity of the brain. It is used to externally drain fluid to relieve elevated intracranial pressure or fluid volume.
The distribution of the recalled product was limited to one distributor in Indiana. The source text states that the product was not further distributed to end users. Potential adverse events associated with the endotoxin failure include immune responses ranging from non-specific febrile reactions to life-threatening systemic inflammatory response syndrome (SIRS).
The recalled product
- Product
- VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of…
- Manufacturer
- Cook Inc.
- Affected units
- 250
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 (1)
- lot 8639185
Distribution
Distributed in 1 state:
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