Neomed NeoConnect Enteral Extension Sets Recalled for Incorrect Expiration Date
Neomed Inc is recalling NeoConnect Enteral Extension Sets because the sterile pouch labels display an incorrect expiration date of 2016-11-19 instead of 2019-11-09.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a documentation and packaging labeling error regarding the expiration date, with no reported injuries or illnesses.
Plain-English summary
Neomed Inc is voluntarily recalling 654 boxes (32,700 units) of NeoConnect Enteral Extension with ENFit connector, REF EXT-60NC. The recall is due to a labeling error on the sterile pouch, which states the expiration date is 2016-11-19, whereas the correct expiration date is 2019-11-09. The case and shipper labels display the correct date.
The affected product is intended for use as an extension set for nasogastric, oralgastric, or gastric tube enteral feeding tubes in neonatal and pediatric patients. The device incorporates safety connectors to help mitigate the risk of accidental connection between I.V. and enteral systems.
The recalled units were distributed in the United States to California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas. The lot number is 20161110. Users should stop using the affected sterile pouches and contact Neomed Inc for further instructions.
The recalled product
- 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…
- Manufacturer
- Neomed Inc
- Category
- Medical Device — Enteral Feeding
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- (UDIs) on the shipper [(01)20817584012015 (17)191109 (10)20161110]
Distribution
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