Class III — Neomed Inc
| Recalling firm | Neomed Co., Ltd. |
|---|---|
| Registered facility | NEOMED CO., LTD. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. The case label and the shipper label have the correct date |
| Product | NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V. system to the enteral system or the enteral system to an I.V. system. This device is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements. |
| Quantity | 654 boxes (32700 units) |
| Distribution | US Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas. |
| Initiated | 2018-10-24 |
| Classified | 2018-11-30 |
| Terminated | 2020-09-16 |
| Recall number | Z-0526-2019 |
| 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 III recall — Neomed Inc (Z-0526-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81452/
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