ICU Medical has recalled over 14 million needle-free access devices after reports of fluid leaks and potential exposure to biological contaminants. The recall affects devices distributed worldwide, including in 50 states and multiple countries. Users must stop using these devices immediately and follow recall instructions from the manufacturer.
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall includes Tego Connectors with reference numbers 011-D1000, 01C-D1000, 055-D1000, D1000, and LAT-D1000. ICU Medical distributed approximately 14,684,607 units globally. These devices were sold in the U.S. and various international markets.
The silicone seal on these devices may bulge, separate, or tear, which can lead to fluid leaks and occluded fluid flow. This malfunction could cause delayed or interrupted therapy, and expose patients to biological contaminants or air infusion.
The FDA classified this issue as a Class II recall. Reports indicate a high risk of incidents related to device malfunction, though specific injury numbers were not provided.
Patients and healthcare providers should cease using these devices immediately. Follow the recall instructions provided by ICU Medical, and contact your healthcare provider for further guidance.
For more information, contact ICU Medical at their customer service number or visit their website. Detailed information about the recall is also available on the FDA website.
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