Recall Z-0526-2019— Neomed Inc

Name: FDA recall Z-0526-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-24

Class III · Terminated

Class III FDA medical device recall by Neomed Inc, initiated 2018-10-24, terminated 2020-09-16. It names one FDA 510(k) clearance: K100288. 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: 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.

Recalling firm: Neomed Inc
Classification: Class III
Status: Terminated
Initiated: 2018-10-24
Terminated: 2020-09-16
Firm location: Woodstock, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K100288 — NEOMED ENTERAL ONLY EXTENSION SETNeomed, Inc.·cleared 2010-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.