The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• Product Names: Local Lower Extremity Pack, In House Ocular Pack and Closure Kit
• Product Codes: KDD
  • Class 1 Device Recall Local Lower Extremity Pack I (fda.gov)
  • Class 1 Device Recall In House Ocular Pack (fda.gov)
  • Class 1 Device Recall In House Ocular Pack (fda.gov)
  • Class 1 Device Recall Closure Kit (fda.gov)
• Model Numbers:
  • Local Lower Extremity Pack I – AMS10833
  • In House Ocular Pack – AMS12947A
  • In House Ocular Pack – AMS12947
  • Closure Kit – AMS13043
• Distribution Dates: June 8, 2022 to November 27, 2023
• Devices Recalled in the U.S.: 2211
• Date Initiated by Firm: December 22, 2023

Device Use

The Windstone Medical Packaging, Inc. Local Lower Extremity Pack, In House Ocular Pack and Closure Kit are convenience kits for use in general clinical procedures. These convenience kits contain the recalled Nurse Assist Sterile Saline.

The Local Lower Extremity Pack is designed to be used during procedures related to the lower limbs. Examples of these procedures include fixing knee or hip joints, repairing blood vessels, and treating foot problems.

The In-House Ocular Pack is equipped with the necessary instruments and materials to support eye-related interventions, fostering precision, and facilitating a structured environment for ocular healthcare practitioners.

The Closure Kit is designed to be used for wound closure and dressing following various clinical procedures.

These kits ensure that medical practitioners have all the essential tools and supplies at their disposal.

Reason for Recall

Windstone Medical Packaging, Inc. is recalling their Local Lower Extremity Pack, In House Ocular Pack and Closure Kit in direct response to Nurse Assist LLC’s, November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, over sterility concerns. These kits contain Nurse Assist Sterile Saline which could not be verified as having the required sterility assurance (SAL) of 10-6. This is the only saline used in these kits. The recall doesn't affect the integrity of the other kit components.

The use of affected kits may cause serious adverse health consequences, including blood stream infections, urinary tract infections that may turn into bladder problems (cystitis) and, if not treated, may develop into a more serious kidney condition (ascending pyelonephritis), ophthalmic (eye) infections, or respiratory infections such as pneumonia. In the worst-case scenarios, the potential ophthalmic (eye) infections can lead to keratitis (when the cornea gets inflamed or infected), eye pain, photophobia (sensitivity to light), permanent vision impairment, or blindness. People who have certain health problems like weak immune systems, who are otherwise susceptible to infection may be more at risk.

There have been no reports of injury or death.

Who May be Affected

• Health care providers using Windstone Medical Packaging, Inc. Local Lower Extremity Pack, In House Ocular Pack or Closure Kit
• People who receive care using Windstone Medical Packaging, Inc. Local Lower Extremity Pack, In House Ocular Pack or Closure Kit

What to Do

On December 22, 2023, Aligned Medical Solutions on behalf of Windstone Medical Packaging, Inc. sent all affected customers an Urgent Medical Device Recall.

The letter requested customers to:

• Immediately check all inventory for the impacted products and place them under quarantine.
• Once the kit is opened for use, any Nurse Assist sterile saline should be identified and set aside.
• Complete the Recall Reply Form, listing all inventory of affected product by lot number and quantity, within 5 business days and return via email to vdavis@alignedmedicalsolutions.com.
  • Indicate on the Recall Reply Form if a replacement Nurse Assist product is needed.
• Identify all distribution partners and notify them of the product recall with a copy of the notification letter.

Contact Information

Customers in the U.S. with questions about this recall should contact Aligned Medical Solutions at 1-800-637-7056.

Additional Resources:

• Medical Device Recall Database Entry
  • Class 1 Device Recall Local Lower Extremity Pack I (fda.gov)
  • Class 1 Device Recall In House Ocular Pack (fda.gov)
  • Class 1 Device Recall In House Ocular Pack (fda.gov)
  • Class 1 Device Recall Closure Kit (fda.gov)
• Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Nurse Assist Sterile Saline Placed Into the Following Kits; AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit
• Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication
• Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.