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U.S. Department of Health and Human Services

Class 2 Device Recall VentriClear

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 Class 2 Device Recall VentriClearsee related information
Date Initiated by FirmMay 31, 2018
Create DateAugust 12, 2018
Recall Status1 Terminated 3 on April 11, 2019
Recall NumberZ-2791-2018
Recall Event ID 80492
510(K)NumberK011812 
Product Classification Catheter, ventricular (containing antibiotic or antimicrobial agents) - Product Code NHC
ProductVentriClear 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 relieving elevated intracranial pressure or fluid volume.
Code Information lot 8639185
FEI Number 1820334
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
800-457-4500
Manufacturer Reason
for Recall		This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).
FDA Determined
Cause 2		Release of Material/Component prior to receiving test results
ActionOn May 31, 2018, the firm contacted the single customer (a distributor) who received the entirety of the affected lot, via email. The email alerted the customer that the lot failed endotoxin testing and instructed the customer to quarantine the lot immediately. The firm then conducted a teleconference with the distributor to further discuss interim controls for future lot release. The recalling firm requested return of the affected lot. The distributor returned the lot to the firm. The recalling firm stated that none of the product was distributed to end users.
Quantity in Commerce250
DistributionOne distributor in Indiana; product was not further distributed to end users.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = NHC
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