NeoConnect Enteral Extension Set recallZ-0526-2019 · Neomed Inc · initiated Oct 24, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Neomed Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-0526-2019
- Status
- Terminated
- Initiated by the company
- Oct 24, 2018
- Recalling firm
- Neomed Inc
- Quantity
- 654 boxes (32700 units)
- Product code
- KNT
- FDA submissions
- K100288
- Distribution
- US Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas.
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.
Code information (models, lots, serial numbers)
(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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NeoConnect Enteral Extension Set EXT-60NCNeomed, Inc. · Tubes, Gastrointestinal (And Accessories)1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K100288 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ENFit Extension Set PEXT-60YNCAvanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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