Zyno Medical Administration Set — Class II medical device recall Z-2895-2016
Terminated recall by Zyno Medical LLC, reported 2016-10-05, distributed nationwide. Administration Set potential filter leaking
| Recall number | Z-2895-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zyno Medical LLC, Natick, MA, United States |
| Recall initiated | 2016-07-29 |
| Classified | 2016-09-27 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2017-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 78,063 sets |
| Reason classes | packaging |
| Lot numbers | 14015279, 14026620, 14046841, 14055191, 14055786, 14056225, 14085742, 14085743, 15035297, 15045940, 15045941, 15046600, 15066912, 15075253, 15075275, 15075835, 15075990, 15076261, 15076304, 15076761, 15085107, 15086621, 15095200, 15095647, 15097179, 15105595, B2-70071-DF-120 |
Product
Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.
Reason for recall
Administration Set potential filter leaking
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-2895-2016. 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.