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.
FDA Recall Z-0526-2019 · Posted None
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Recalling FirmNeomed Inc
Recall StatusTerminated
Product CodeKNT
Date Initiated2018-10-24
Date Terminated2020-09-16
Product Quantity654 boxes (32700 units)
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
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].
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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