Elevated risk U.S. Food and Drug Administration

Aligned Medical Solutions Convenience kits containing saline recall: Product cannot be verified as having the required sterility assurance level

Recall published 2+ years ago

Product cannot be verified as having the required sterility assurance level

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4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Water-based medical products that are nonsterile and potentially contaminated with bacteria could cause serious or life-threatening infections.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
January 22, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Aligned Medical Solutions
Product type
Medical devices
Distribution
Nationwide
Reports of harm
No injuries have been reported to date.

Products covered by this recall

Convenience kits containing saline

What the company announced

On December 22, 2023, Aligned Medical Solutions, Billings, MT, 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.

Recalled products include:

  • Brand: Kit Name · Aligned Medical Solutions: Product Code · DI Number · Lot
  • Brand: Local Lower Extremity Pack I · Aligned Medical Solutions: AMS10833 · B098AMS108330 · 173179, 176590, 174338, 175529, 176217, 178271, 178489, 180907, 183355, 181439, 183674, 184398, 185064, 188137, 189007, 189640, 189641, 189642, 191067, 192551, 194252, 196380, 197727, 198046, 197727, 198373, 199297
  • Brand: In House Ocular Pack · Aligned Medical Solutions: AMS12947 · B098AMS129470 · 192389, 194805
  • Brand: In House Ocular Pack · Aligned Medical Solutions: AMS12947A · B098AMS12947A0 · 192436, 192774, 196582
  • Brand: Closure Kit · Aligned Medical Solutions: AMS13043 · B098AMS130430 · 178114, 187325, 191102, 195504, 196502, 197864

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 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nurse-assist-llc-issues-recall-09-sodium-chloride-irrigation-usp-and-sterile-water-irrigation-usp

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 06/02/2022 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 labeling and replacement product if needed at 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].

Customers with questions may contact the company via telephone at 1-800 -637-7056 between the hours of 8:00 am and 5:00 pm (Mountain Time). Customers may also contact the company via e-mail at [email protected] .

Please contact your McKesson Sales Rep or Vicki Davis at [email protected] / 406-259-6387 for replacement product.

Aligned Medical Solutions has notified the FDA of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • DYND40540 110ML
  • 560284 100ML

Package size

Match the net weight or the piece count on the front of the pack.

  • 110 ML
  • 100 ML

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Aligned Medical Solutions — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: Contact the Quality Department for further instructions on labeling and replacement product if needed at 406.259.6387.

Company contact: Aligned Medical Solutions — Consumers: Aligned Medical Solutions, 1-800 -637-7056, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Aligned Medical Solutions medical devices recalled?

Product cannot be verified as having the required sterility assurance level Water-based medical products that are nonsterile and potentially contaminated with bacteria could cause serious or life-threatening infections.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number DYND40540 110ML, 560284 100ML. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The notice says: Contact the Quality Department for further instructions on labeling and replacement product if needed at 406.259.6387.

Where was the recalled product sold?

It was distributed nationwide.

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