Avanos Medical, Inc. recalls MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT

Recalled July 31, 2024 · FDA recall Z-2422-2024 · Avanos Medical

Hazard

The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications. · FDA Class II

Units

53,384 kits

Sold at

Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia.

Description

The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

Product

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 - Non-ENFit; 2. 0270-16- - 16 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 3. 0270-18- - 18 Fr, all sizes - Non-ENFit; 4. 0270-22- - 22 Fr, all sizes - Non-ENFit; 5. 8270-14- - 14 Fr, all sizes (ENFit); 6. 8270-16- - 16 Fr, all sizes (ENFit); 7. 8270-18- - 18 Fr, all sizes (ENFit); 8. 8270-22- - 22 Fr, all sizes (ENFit).

Manufacturer(s)

Avanos Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →