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 | Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly. |
| Product | Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC |
| Quantity | 1604 |
| Distribution | Nationwide domestic distribution. Foreign distribution to Australia, Belgium, Canada, China, Colombia, Denmark, France, Germany, Italy, Korea, Netherlands, New Zealand, Peru, Russia, Spain, Sweden, and United Kingdom. |
| Initiated | 2019-12-27 |
| Classified | 2020-01-16 |
| Terminated | 2020-11-23 |
| Recall number | Z-0815-2020 |
| 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-0815-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84560/
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