Valkyrie LTOWB Recall Lawyer

Combat Medical Systems issued a recall on some of their Valkyrie products, like the low titer group O whole blood (LTOWB) convenience kits. Combat Medical announced a recall on these convenience kits due to possible broken or bent needles.

The recall of the convenience kits was issued on December 23, 2020.

Combat Medical is a registered FDA establishment formed by military and law enforcement experienced medics, managers, and researchers. They are well-versed in making medical devices.

The company’s goal is to eradicate the preventable deaths category on the battlefield. The Combat Medical LLC does this by developing products that simplify the usage of tactical medicine to evacuate the point of injury.

The FDA or the Food and Drug Administration ordered a recall on the Combat Medical’s convenience store kits. The order was categorized as a Class 1 recall, the most severe category, meaning that the device could cause death or critical injuries.

This article focuses on addressing the issues faced by Combat Medical’s Valkyrie LTOWB recall and suggesting ways to help with the recall.

What Is Valkyrie LTOWB?

Combat focuses on the five leading causes of death following traumatic injury. They concentrate on tackling massive hemorrhages, airways, respiration, circulation, or head and hypothermia complications.

So, they go about preventing these from happening by producing and delivering medical devices to provide swift first-aid.

Valkyrie LTOWB is a blood transfusion system set that is self-contained and is low cube. It provides solutions by assisting organizations to pre-identify low titer group O blood donors.

The Valkyrie LTOWB collection set has the necessary components required to collect fresh blood from the field. The collection set is usually paired with the Valkyrie LTOWB Administration set to complete the transfusion requirements.

The manufacturing date of the Valkyrie LTOWB devices was 1^st  July 2019. The product is classified as a blood transfusion kit.

Combat Medical Systems, LLC, is located at 5555 Harrisburg Ind Pk Dr, Harrisburg NC 28075-7407. For further information on the products, contact the Director of Global Regulatory Affairs, Kimberly Reed (Recall coordinator), through mobile (855-428-6074) or e-mail them.

What Is Valkyrie LTOWB Intended To Treat?

The Valkyrie LTOWB is majorly a blood transfusion device that helps to identify low titer type O donors. It combats hemorrhages or helps massive blood loss patients get the necessary blood in the military or army.

The transfusion sets serve as tactical treatments, which help when urgent life-saving is needed at the point of injury.

The low titer group O whole blood (LTOWB) gets provided at the point of injury (POI) for patients facing hemorrhage shocks. This blood transfusion system has greatly helped people in the navy and military grounds survive on the battlefields.

What Does the Valkyrie LTOWB Do?

The Valkyrie low titer group O whole blood (LTOWB) helps identify low titer donor blood and transfer this blood to the needed patients quickly in the battleground. It thus acts as first-aid in treating patients and providing them blood immediately to survive the point of injury.

All the recalled convenience kits came with a package for carrying the blood with an attached needle. They also provide the essential components for blood screening.

Why Are The Valkyrie Transfusion Kits Being Recalled?

As the LTOWB saves the patient from losing blood or hemorrhaging, one might wonder why Combat Medical decided the recall. The recall was issued because the needle connected to the blood bag could cause harm to patients.

The needle in the convenience kits attached to the blood bag has a risk of bending or disconnecting. Since the damage of the needle is likely to happen, the products were recalled.

Moreover, the breakage or bend in the needle would not be noticeable to the user unless the pack in use is opened. Also, once the pack gets opened, the kit is susceptible to contamination.

There are many risks in using a damaged needle.

• It can cause bruises in the injured area or blood clotting (hematoma).
• The needed blood might not reach the patients at the right time. Thus, issues like inability or delay in treating the patients at the right time can result in death or serious injury.
• The kit is susceptible to contamination of blood due to the bent/disconnected needle.

This issue had about four complaints registered. However, there have not yet been any complaints of injuries and death.

This damage to the needle affects the patients and blood donors who require this kit. It might also affect the health care providers who use the contaminated combat medical convenience kits.

The Model Number Of The Products Recalled

The Combat company devices and their models recalled are noted down below:

• The Valkyrie LTOWB collection and administration set models: NSN 6515016862423, 80-821 NSN 6515016862401, and 80-820.
• The Low Titer Type O FWB Transfusion Set and Low Titer Type O Donor Collection Set of the models: 80-875-D and 80-875 NSN 651501684994.
• The Fresh Whole Blood Transfusion and Donor Set models: 80-801-D NSN 6515016640306 and 80-801 NSN 6515016574750

What Can You Do?

Careful inspection of the transfusion kits should get administered to detect the recalled products efficiently. Note all the product models that got recalled and seize the product from usage if you spot them.

All the impacted consumers and distributors received a recall notice letter from Combat Medical Systems, LLC. The letter provided much-needed insights on knowledge to spot the needle breakage and figure out what to do with the convenience kits.

• Remove all the affected kits from usage.
• Send back all the damaged products to Combat Medical along with the completed Recall Receipt and Acceptance form.
• For any further queries on the recall, contact this number 855-428-6074 or e-mail

Endnotes

The Combat Medical Valkyrie LTOWB convenience kits have gotten recalled due to possible broken or bent needles. The FDA classified the device under Class I recall. They also advise stopping the usage of the broken or disconnected needles immediately.

The convenience kits that offer immediate blood to treat the site of injury are highly advantageous. However, broken or bent needle usage can prove to be lethal to the patient’s health and cause adverse effects.

Please note that none of the information contained on this website constitutes medical information or medical advice. This page concerns news regarding an FDA product recall. Additional details and up-to-date information can be found by contacting the FDA. If you suspect you may be impacted by the recall, seek medical help immediately.