Elevated risk U.S. Food and Drug Administration

Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits recall: Potential Lack of Sterility Assurance

Recall published 2+ years ago

Potential Lack of Sterility Assurance

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: This deficiency may lead to non-sterile products, posing a risk of the water coming into contact with a patient’s surgical site.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
February 21, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Avanos Medical
Product type
Medical devices

Products covered by this recall

MIC* Gastric-Jejunal Feeding Tube Kits

What the company announced

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 [email protected] .

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-2024-001

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 [email protected] or call (855) 201-1355.

Download Product List Here:

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

What to do about Sterility

Avanos Medical — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  3. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  4. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: Destroy all affected lots in inventory.

Company contact: Avanos Medical, Inc. — Consumers: (855) 201-1355, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Avanos Medical medical devices recalled?

Potential Lack of Sterility Assurance This deficiency may lead to non-sterile products, posing a risk of the water coming into contact with a patient’s surgical site.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The notice says: Destroy all affected lots in inventory.

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