Device 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.
Z-0526-2019
Product summary
- Firm
- Neomed Inc
- Event
- Event 81452
- Status
- Terminated
- Classification
- Class III
- Quantity
- 654 boxes (32700 units)
- Official record key
device-enforcement:Z-0526-2019
Official wording
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
Code information: (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
Distribution pattern: US Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas.
Derived failure modes
-
Unknown
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