Safety Report: Aligned Medical Solutions Convenience kits containing saline - recalled due to safety concerns, USA

United States

Aligned Medical Solutions, initiated a nationwide recall of Convenience kits containing saline because the Product cannot be verified as having the required sterility assurance level. Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Aligned Medical Solutions distributed these kits nationwide in the USA. Recalled Product(s) were manufactured from 06/028/2022 to 11/20/23 and distributed from 06/08/2022 to 11/27/2023. No injuries have been reported to date.

Water-based medical products that are nonsterile and potentially contaminated with bacteria could cause serious or life-threatening 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 they are exposed to contaminated water-based medical products.

Recalled products apply to the following kits: AMS10833 Local Lower Extremity Pack I, AMS12947 In-House Ocular Pack, AMS12947A In-House Ocular Pack, and AMS13043 Closure Kit. Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Details are attached.

These convenience kits contain the recalled Nurse Assist Sterile Saline, Brand Name - Medline Medical part # DYND40540 110ML Sterile Saline Cup or Nurse Assist Sterile Saline Brand Name - McKesson Medical part # 560284 100ML Sterile Saline Bottle, which has been recalled because the Nurse Assist product cannot be verified as having the required sterility assurance level (SAL) of 10-6. See Nurse Assist Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation

Customers who have affected products should immediately review their inventory and quarantine all affected kits. Contact the Quality Department for further instructions on labeling and replacement products if needed. Customers will be provided with a label that is to be placed on the packs containing the recalled Nurse Assist Sterile Saline. Aligned Medical Solutions is notifying its distributors by email and will arrange for labels to identify the packs with the recalled sterile saline. At the time the kit is opened for use, Nurse Assist sterile saline should be identified, and quarantined according to the medical waste policies in effect in your institution. All other components in the kit are not affected by this recall. Aligned Medical Solutions will also arrange for replacement sterile saline to be sent for all recalled product[s].

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: Aligned Medical Solutions
Brand name: Aligned Medical Solutions
Product recalled: Convenience kits containing saline
Reason for the recall: The product cannot be verified as having the required sterility assurance level
FDA Recall date: January 23, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/windstone-medical-packaging-dba-aligned-medical-solutions-issues-nationwide-recall-nurse-assist