Recalls / —
—#165597
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 relieving elevated intracranial pressure or fluid volume.
- FDA product code
- NHC — Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K011812
- Affected lot / code info
- lot 8639185
Why it was recalled
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).
Root cause (FDA determination)
Release of Material/Component prior to receiving test results
Action the firm took
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.
Recalling firm
- Firm
- Cook Inc.
- Address
- 750 N Daniels Way, Bloomington, Indiana 47404-9120
Distribution
- Distribution pattern
- One distributor in Indiana; product was not further distributed to end users.
Timeline
- Recall initiated
- 2018-05-31
- Terminated
- 2019-04-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165597. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.