NEOCONNECT — Class III medical device recall Z-0526-2019
Terminated recall by Neomed Inc, reported 2018-12-12, distributed in CA, FL, IL, MI, NJ, OH, TN, TX. The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-0
| Recall number | Z-0526-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neomed Inc, Woodstock, GA, United States |
| Recall initiated | 2018-10-24 |
| Classified | 2018-11-30 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2020-09-16 |
| Distributed | CA, FL, IL, MI, NJ, OH, TN, TX |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 00817584012011, 10817584012018, 20817584012015 |
| Lot numbers | 20161110 |
| Model numbers | EXT-60NC |
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.
Reason for recall
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
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-0526-2019. 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.