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 | The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product. |
| Product | Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT |
| Quantity | 97 |
| Distribution | No distribution in the US. Products were distributed to the following foreign countries: China. |
| Initiated | 2019-05-02 |
| Classified | 2019-06-13 |
| Terminated | 2019-08-23 |
| Recall number | Z-1780-2019 |
| 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-1780-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82910/
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