Medline Industries is recalling 1,145 units of its General Surgery Trays because they contain a defective component: the Stryker Color Cuff Sterile Disposable Tourniquet Cuff. A manufacturing defect in the tourniquet cuff may cause its flange to detach from the internal bladder, leading to a loss of air pressure. This failure can prevent the device from maintaining the pressure needed to stop blood flow during surgery, creating a significant risk of patient hemorrhaging. These trays are customized kits provided sterile for single-use in various surgical procedures.
If the tourniquet cuff fails during a surgical procedure, it may result in unexpected and significant blood loss for the patient. This detachment of the connection point compromises the surgical field and increases the risk of serious hemorrhaging and related complications.
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs.
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs.
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs.
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs.
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs.
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs.
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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