Zyno Medical Administration Set -105"ADMIN SET 20DP — Class II medical device recall Z-2058-2019
Terminated recall by Zyno Medical LLC, reported 2019-07-31, distributed in MA. Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administrat
| Recall number | Z-2058-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zyno Medical LLC, Natick, MA, United States |
| Recall initiated | 2019-05-29 |
| Classified | 2019-07-23 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2020-06-22 |
| Distributed | MA |
| UPC / GTIN / UDI-DI | 00814371020198 |
| Lot numbers | 18037128, 18065375, 19015969 |
Product
Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2058-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.