Class II — Cook Inc.
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | VentriClear® II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain. |
| Quantity | 35 |
| Distribution | Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia. |
| Initiated | 2015-11-19 |
| Classified | 2015-12-14 |
| Terminated | 2017-02-22 |
| Recall number | Z-0416-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Inc. (Z-0416-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72718/
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