Z-0526-2019Class III

NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension...

Name: Z-0526-2019 NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension...
Creator: Neomed Inc
Published: 2018-10-24
License: https://open.fda.gov/license/

Halyard Health / initiated 2018-10-24 / Terminated / root cause: labeling and UDI

FDA source

Neomed Inc began a recall of 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... on 2018-10-24. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0526-2019
Classification: Class III
Status: Terminated
Initiated: 2018-10-24
Posted: 2018-11-30
Terminated: 2020-09-16
Recalling firm: Halyard Health
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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm, NeoMed, sent an URGENT: MEDICAL DEVICE RECALL" letter dated 10/24/2018 to its consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: Please contact NeoMed Quality Assurance by email to [email protected] to confirm receipt of this letter and obtain a Return Materials Authorization for any units identified above that remain in your inventory. Or, you may mail the enclosed reply card to NeoMed Inc., 100 Londonderry Ct #112, Woodstock, GA 30188. If you have any questions, call 770-516-2225 or email: [email protected].
Quantity in commerce: 654 boxes (32700 units)
Distribution: US Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas.
Product codes and lots: (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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0526-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0526-2019	Class III	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30

Product code KNT

K100288Class IINeomed Enteral Only Extension SetNeomed, Inc. / cleared 2010-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)