Recall Z-0526-2019 ยท KNT Tubes, Gastrointestinal (And Accessories)
Neomed Inc
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 devic
| Date | Oct 24, 2018 |
| Status | Terminated |
| Reason | 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 | 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 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 |
| Quantity | 654 boxes (32700 units) |
| Distribution | US Distribution to states of: California, Florida, Illinois, Michigan, New Jersey, Ohio, Tennessee, and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100288 | NEOMED ENTERAL ONLY EXTENSION SET Neomed, Inc., Aug 3, 2010 |