Elevated risk U.S. Food and Drug Administration

Medline and Centurion Convenience kits recall: The potential for a lack of sterility

Recall published 2+ years ago

The potential for a lack of sterility

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: The Nurse Assist recall was issued due to the potential for a lack of sterility, which could result in non-sterile products.

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
April 5, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Medline and Centurion
Product type
Medical devices

Products covered by this recall

Convenience kits

What the company announced

Northfield, Ill., Apr. 5, 2024 – In direct response to the Nurse Assist, LLC voluntary product recall initiated on November 6, 2023, for saline and sterile water medical products, Medline Industries, LP initiated a nationwide recall on November 15, 2023, for its Medline and Centurion branded convenience kits containing Nurse Assist 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP. The Nurse Assist recall was issued due to the potential for a lack of sterility, which could result in non-sterile products.

Water-based medical products that are non-sterile and potentially contaminated could cause serious or life-threatening infections, including bloodstream, urinary tract, open wound/soft tissue, and respiratory infections. Patients who are elderly, critically ill, have weak immune systems (including newborn infants, pregnant women, and cancer patients), or have chronic diseases are particularly at risk of infection. However, other patients could also develop infections after exposure to contaminated water-based medical products.

Medline Industries, LP has received one adverse event associated with product manufactured by Nurse Assist.

The recall affects Medline and Centurion convenience kits that may be used at home by patients, caregivers, and home health providers, as well as convenience kits that may be used in medical settings for surgery or other medical procedures. Recalled kits include, but are not limited to, wound care kits, tracheostomy kits and catheter kits. A detailed list of recalled Medline and Centurion convenience kits, as well as an example of product labeling, can be found here .

Consumers who have recalled product should stop using the product and contact Medline immediately.

Medline Industries, LP notified its direct distributors and consumers of the Nurse Assist recall by First Class Mail and email on 11/16/23, upon receipt of initial recall notification from Nurse Assist. Customers who received the recalled product were given instructions to quarantine all affected products immediately and provide Medline with a response regarding the affected quantity on hand. Upon confirmation of the affected quantity, Medline provided customers with over-labels to place on the affected inventory, with instructions for staff to remove the affected component before using the kit. The recall notification also instructed distributors and those who resold or transferred affected product to another company or individuals to notify their customers of this recall notification.

Consumers with questions regarding this recall can contact Medline Industries, LP by phone at 866-359-1704 or [email protected] , Monday through Friday between the hours of 8am and 5pm CST.

Medline Industries, LP distributed these product(s) to medical facilities, distributors, and hospitals located within and outside of the United States from 12/01/2021 to 11/10/2023. The kits containing the affected Nurse Assist product(s) have varying expiration dates, the latest expiration date being September 18, 2025.

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

Medline and Centurion — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  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.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Medline Industries, LP — Consumers: 866-359-1704, [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 Medline and Centurion medical devices recalled?

The potential for a lack of sterility The Nurse Assist recall was issued due to the potential for a lack of sterility, which could result in non-sterile products.

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 purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

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