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 | Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device. |
| Product | Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax. |
| Quantity | 41 units |
| Distribution | US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH. |
| Initiated | 2019-09-17 |
| Classified | 2019-11-21 |
| Terminated | 2020-05-21 |
| Recall number | Z-0506-2020 |
| 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-0506-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83921/
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