Medline and Centurion Convenience kits - recalled due to lack of sterility, USA
1 week ago •source www.fda.gov
Recall notice
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
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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. Medline Industries, LP has received one adverse event associated with product manufactured by Nurse Assist.
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.
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 in the link below.
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.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Medline Industries, LP
Brand name: Medline and Centurion
Product recalled: Convenience kits
Reason of the recall: The potential for a lack of sterility
FDA Recall date: April 08, 2024
Source: www.fda.gov
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.
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 in the link below.
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.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Medline Industries, LP
Brand name: Medline and Centurion
Product recalled: Convenience kits
Reason of the recall: The potential for a lack of sterility
FDA Recall date: April 08, 2024
Source: www.fda.gov
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