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U.S. Department of Health and Human Services

Class 3 Device Recall NeoMed NeoConnect Enteral Extension Sets with ENFit Connectors

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 Class 3 Device Recall NeoMed NeoConnect Enteral Extension Sets with ENFit Connectorssee related information
Date Initiated by FirmOctober 24, 2018
Create DateNovember 30, 2018
Recall Status1 Terminated 3 on September 16, 2020
Recall NumberZ-0526-2019
Recall Event ID 81452
510(K)NumberK100288 
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
ProductNEOCONNECT, 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 (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
FEI Number 3011270181
Recalling Firm/
Manufacturer		 Neomed Inc
100 Londonderry Ct Ste 112
Woodstock GA 30188-7353
For Additional Information Contact
770-516-2225
Manufacturer 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
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 recall@neomedinc.com 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: bryan@brosseauconsult.com.
Quantity in Commerce654 boxes (32700 units)
DistributionUS Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = KNT
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