Class II — COVIDIEN LLC
| Recalling firm | Covidien llc |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen. |
| Product | MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 8817232019 8817277007 8817277011 8817277021 8817277027 8830414001 8830414002 8830415001 8830415003 8830416001 8830416003 8830416021 8830416023 8831173010 8831173011 8831173012 8831661001 8831662001 8831663001 8831663002 8831663021 8831663022 8832539001 8832539002 8832539003 88325… |
| Quantity | 2,223,067 |
| Distribution | Nationwide domestic distribution. Foreign distribution to Canada, Australia, New Zealand, Latin America, and Hong Kong. |
| Initiated | 2019-04-29 |
| Classified | 2019-07-09 |
| Terminated | 2024-01-09 |
| Recall number | Z-1955-2019 |
| 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 — COVIDIEN LLC (Z-1955-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82802/
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