Nancy posted: " www.fda.gov COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announceme" Read on blog or Reader "OUR WORLD" Read on blog or Reader Avanos Medical, Inc. Announces Voluntary Recall in Response to Nurse Assist, LLC Sterile Water Medical Products Recall Nancy March 1 www.fda.gov COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company Announcement Date: February 21, 2024 FDA Publish Date: February 27, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential Lack of Sterility Assurance Company Name: Avanos Medical, Inc. Brand Name: Product Description: Product Description MIC* Gastric-Jejunal Feeding Tube Kits Company Announcement ALPHARETTA, Ga., Feb. 7, 2024 / -- In direct response to the Nurse Assist, LLC voluntary recall of pre-filled syringes and other sterile water products, Avanos Medical, Inc. (NYSE: AVNS) voluntarily recalled specific lots of MIC* Gastric – Jejunal Feeding Tube Kits on Jan. 16, 2024. These kits include Nurse Assist supplied syringes, pre-filled with sterile water, essential for inflating the retention balloon of the feeding tube. The Nurse Assist voluntary recall was initiated due to concerns about the potential lack of sterility assurance in these water-based products. This deficiency may lead to non-sterile products, posing a risk of the water coming into contact with a patient's surgical site. Any open wound exposed to non-sterile products could potentially put the patient at risk of infection. The pre-filled syringe is the only item in the Avanos feeding tube kit affected by the Nurse Assist recall. As of Feb. 6, 2024, the FDA reported receiving adverse events associated with use of Nurse Assist products and is further evaluating this information. Avanos has not been directly contacted with any reported adverse events. Upon evaluating the impact of the Nurse Assist recall, Avanos has identified the affected MIC* Gastric – Jejunal Feeding Tube Kit product codes and lot numbers. Customers receiving the listed lots are instructed to remove all affected kits from facilities and requested to take the following actions: Continue normal post-op care for any newly placed MIC* GJ tube. Report any adverse events involving these products immediately to PIQ@avanos.com. Check all storage facilities and warehouse locations for affected products and quarantine them. Complete the Customer Response Form: https://iqvia-response.my.site.com/mt/fca?cid=avanos-fca-2024-001External Link Disclaimer Destroy all affected lots in inventory. Notify other departments or customers of this recall. *Registered Trademark or Trademark of Avanos Medical, Inc., or its affiliates. © 2018 AVNS. All rights reserved. For additional questions related to this recall, please reach out to avanos-fca-2024-001@iqvia.com or call (855) 201-1355. Download Product List Here: Company Contact Information https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avanos-medical-inc-announces-voluntary-recall-response-nurse-assist-llc-sterile-water-medical Comment Like You can also reply to this email to leave a comment.

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