FDA warns – Avanos Medical, Inc. recalls certain lots of MIC Gastric – Jejunal Feeding Tube Kits after Nurse Assist, LLC recall

On February 21, 2024, Avanos Medical, Inc., of Alpharetta, Georgia, announced a voluntary recall of certain lots of its MIC Gastric – Jejunal Feeding Tube Kits following Nurse Assist, LLC’s own voluntary recall of pre-filled syringes, among other sterile water products.

Officials note that the affected Avanos Medical kits contains the now-recalled Nurse Assist syringes, which are pre-filled with sterile water and are critical in the inflation of the feeding tube’s retention balloon.

Initiated following concerns that the sterility of the water-based products could not be assured, Nurse Assist’s recall is meant to safeguard against non-sterile products, and non-sterile water, contaminating a surgical site and potentially putting a patient at risk of infection. Beyond the pre-filled syringe, no other item in Avanos Medical’s feeding tube kit is impacted by Nurse Assist’s recall.

Certain product codes and lot numbers of the MIC Gastric – Jejunal Feeding Tube Kit was identified in Avanos Medical’s recall after a further evaluation of Nurse Assist’s recall. Customers who may have received the impacted lots are asked to assess inventories at their given facilities and remove any affected kits. The following are requested:

  • For any recently-placed MIC GJ tube, resume standard post-operation care.
  • If any adverse events in connection to the products are observed, immediately report the incidents to PIQ@avanos.com.
  • Quarantine any affected products found in storage facilities and warehouse locations.
  • Complete and submit the Customer Response Form.
  • Destroy and discard any affected lots found in inventory.
  • Ensure that all related departments and customers are aware of the recall.

Further questions and concerns related to the recall should be directed to the company at avanos-fca-2024-001@jqvia.com, or by calling (855) 201-1355.

 

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