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Aligned Medical Solutions, Billings, MT, has initiated a nationwide recall of Nurse Assist Sterile Saline which is piggybacked [attached to the outside of the kit in a separate pouch] 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. 

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.

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.

Aligned Medical Solutions distributed these kits nationwide. 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.

Customers who have affected product[s] should immediately review their inventory and quarantine all affected kits. Contact the Quality Department for further instructions on labelling and replacement product if needed on 406.259.6387. 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, quarantined, and disposed of pursuant 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].

Aligned Medical Solutions has notified the FDA of this action.

Source: FDA