medical Class III Updated 2018-12-12

Neomed Inc recalls NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: US Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas.
Lot/Code Info: (UDIs) on the shipper [(01)20817584012015 (17)191109 (10)20161110], case [(01)10817584012018 (17)1991109 (10)20161110] and pouch [(01)00817584012011 (17)191109 (10)20161110] Lot Number: 20161110
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