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).

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

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 a QR code for the distributor or customer to access for an electronic version of the updated IFU. A Field Correction Acknowledgment form was enclosed with the distributor and customer letters for completion and return within 3 business days upon receipt of the notification. It contains a QR code to be scanned to acknowledge receipt of the notice and to complete the customer response form online. Distributors were requested to inform their customers regarding the notification and to provide them a copy of the undated Distributor Customer Letter which outlines much of the same information that is contained in the distributor and customer notification letter.