VentriClear¿ II Ventricular Drainage Catheter Set — Class II medical device recall Z-0416-2016
Terminated recall by Cook Inc., reported 2015-12-23, distributed in FL, MI, PA, TN. Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage C
| Recall number | Z-0416-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2015-11-19 |
| Classified | 2015-12-14 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2017-02-22 |
| Distributed | FL, MI, PA, TN |
| Countries outside the US | SA |
| Quantity | 35 |
| Reason classes | labeling |
| Model numbers | 50318LOT, F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X |
Product
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Reason for recall
Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0416-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.