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

FDA device recall Z-2422-2024 · posted 2024-07-23 · Open, Classified

Recall details

Recalling firm

Avanos Medical, Inc.

Reason for recall

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

Action taken

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.

Root cause

Error in labeling

Status

Open, Classified

Product code

KNT

Quantity affected

53,384 kits

Distribution

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

Date initiated

2024-05-31

Date posted

2024-07-23

Location

Alpharetta, GA

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