Woodstock, GA, United States
Neomed Inc recalls
2 recalls recorded since 2018, most recently on 24 October 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 24 October 2018
- Terminated
- 16 September 2020
- 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
- Distribution
- US Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0526-2019
- 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 tu
Terminated Class II Medical devices
- Recall started
- 4 June 2018
- Terminated
- 21 July 2020
- Reason
- Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0093-2019
- NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.