Class II — Zyno Medical LLC
| Recalling firm | Zyno Medical LLC. |
|---|---|
| Registered facility | Zyno Medical LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified |
| Product | Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F |
| Quantity | 360 cases (50/case)=18,000 |
| Distribution | MA |
| Initiated | 2019-05-29 |
| Classified | 2019-07-23 |
| Terminated | 2020-06-22 |
| Recall number | Z-2059-2019 |
| 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 — Zyno Medical LLC (Z-2059-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83026/
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