Covidien and Cardinal Health Urology and OR room specific kits and trays - recalled due to lack of sterility assurance, USA

United States

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 a non-sterile product. There have been no reports of patient harm.

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. Our top priority is the safety of patients.

After reviewing the impact of the Nurse Assist recall, Cardinal Health has identified the affected Covidien and Cardinal Health™ brand codes and lot numbers, you can see them in the link below.

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 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 acknowledgment form to them.
- RETURN their enclosed Acknowledgment Form confirming receipt of this action and the completion of over labeled product

Company name: Cardinal Health
Brand name: Covidien and Cardinal Health
Product recalled: Urology and OR room-specific kits and trays
Reason for the recall: Potential lack of sterility assurance which could result in non-sterile product
FDA Recall date: December 07, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-issues-medical-device-recall-nurse-assist-products-contained-within-kitstrays