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 relieving elevated intracranial pressure or fluid volume.
FDA Recall Z-2791-2018 · Posted None
Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeNHC
Date Initiated2018-05-31
Date Terminated2019-04-11
Product Quantity250
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).
Firm Action
On 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.
Root Cause
Release of Material/Component prior to receiving test results
Distribution Pattern
One distributor in Indiana; product was not further distributed to end users.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.