Elevated risk U.S. Food and Drug Administration

Covidien and Cardinal Health Expanded list of Urology and OR room specific kits recall: Potential lack of sterility assurance which could result in non-sterile

Recall published 2+ years ago Last updated

Potential lack of sterility assurance which could result in non-sterile product

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: Under the Nurse Assist voluntary recall, this product is being recalled due to the potential for a lack of sterility assurance which could result in non-sterile product.

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
December 7, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Covidien and Cardinal Health
Product type
Medical devices
Reports of harm
There have been no reports of patient harm.

Products covered by this recall

Expanded list of Urology and OR room specific kits and trays Urology and OR room specific kits and trays

What the company announced

In direct response to the Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. Under the Nurse Assist voluntary recall, this product is being recalled due to the potential for a lack of sterility assurance which could result in non-sterile product.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events. There have been no reports of patient harm. Our top priority is the safety of patients.

After reviewing the impact of the Nurse Assist recall, Cardinal Health has identified the below affected Covidien and Cardinal Health™ brand codes and lot numbers.

Customers who received the listed lots were given instructions to:

QUARANTINE affected kits/trays.

ALERT clinicians of the recalled component(s).

AFFIX a WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s).

NOTIFY other departments, facilities or customers within the customer’s hospital system, if they have transferred the affected kits/trays, and provide a copy of the notice and recall acknowledgement form to them.

RETURN their enclosed Acknowledgment Form confirming receipt of this action and the completion of over labeled product via fax to 614.652.9648.

For additional questions related to this recall, please reach out to: [email protected] or call 800-292-9332.

On December 21, 2023, Cardinal Health issued an additional notice to customers with an expanded list of impacted products. Please see the complete list here: Expanded Affected Covidien and Cardinal Health ™

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.

How this recall developed

The company posted 2 announcements about this recall on fda.gov. They are kept together on this page: the products, codes and places listed above are combined from all of them, and the announcement text comes from the most recent English version.

  1. December 7, 2023 — First announcement. Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays Read it on fda.gov
  2. December 21, 2023 — Updated announcement. Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays Read it on fda.gov

What to do about Sterility

Covidien and Cardinal Health — 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: AFFIX a WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s).

Company contact: Cardinal Health — Consumers: 800-292-9332, [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 Covidien and Cardinal Health medical devices recalled?

Potential lack of sterility assurance which could result in non-sterile product Under the Nurse Assist voluntary recall, this product is being recalled due to the potential for a lack of sterility assurance which could result in non-sterile product.

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: AFFIX a WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s).

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