COMPANY ANNOUNCEMENT
Cardinal Health Issues Medical Device Recall for Nurse Assist Products Contained Within Kits/Trays
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 AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
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Recall Reason DescriptionPotential lack of sterility assurance which could result in non-sterile product
- Company Name:
- Cardinal Health
- Brand Name:
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Brand Name(s)Covidien and Cardinal Health
- Product Description:
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Product DescriptionExpanded list of Urology and OR room specific kits and trays
Company Announcement
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: fieldcorrectiveaction@cardinalhealth.com 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™
Link to Original Announcement