Cook Medical Recalls VentriClear II Catheters Due to Sterilization Error
Cook Medical is recalling specific lots of VentriClear II Ventricular Drainage Catheter Sets because double sterilization may reduce the antibiotic coating below labeled levels.
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: The recall is classified as FDA Class II. The hazard involves a reduction in antibiotic coating, which poses a risk of harm (infection) but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
Cook Medical has initiated a voluntary recall of 35 units of the VentriClear II Ventricular Drainage Catheter Set. This medical device allows for the external access and drainage of cerebrospinal fluid from the brain's ventricles.
The recall was triggered because the affected devices were sterilized twice. This process may have resulted in the minocycline and rifampin catheter coating being less than what is indicated on the product labeling.
The affected units were distributed in Tennessee, Florida, Michigan, and Pennsylvania, as well as in Saudi Arabia. The specific catalog number is 50318, and the affected lot numbers are F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, and NS6079166X. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
- Manufacturer
- Cook Inc.
- Affected units
- 35
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 (7)
- Catalog Number: 50318Lot Numbers: F4365351X
- F4692818X
- NS5274254X
- NS5667436X
- NS5727900X
- NS6079165X
- NS6079166X
Distribution
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