Recall Z-2422-2024 ยท KNT Tubes, Gastrointestinal (And Accessories)
Avanos Medical, Inc.
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product codes beginning with the following numbers: 1. 0270-14- - 14 Fr, all sizes except 6.0 cm and 6.5 cm
| Date | Jul 23, 2024 (initiated May 31, 2024) |
| Status | Open, Classified |
| Reason | The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications. |
| Root cause | Error in labeling |
| Action | The recalling firm issued separate letters to distributors and customers on and dated 5/31/2024 via email and FedEx. The letter advised them the firm has updated the IFU to include additional complications associated with the use of the AVANOS MIC-KEY* Gastric-Jejunal Feeding Tubes which is supplied with the product and provides users and patients information about the intended purpose, proper use, and risks associated with the use of the device. The letter outlined the risk information pertaining to potential complications for the affected devices listed in the letter. The letter contains |
| Quantity | 53,384 kits |
| Distribution | Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922667 | MIC LOW PROFILE GASTROSTOMY TUBE Medical Innovations Corp., Dec 1, 1993 |