Recall Z-1904-2025

Reason for recall

The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.

FDA-determined cause: Process control

Action taken

On May 15, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were given detailed information about the incorrect information printed on the tape. Customers were instructed to identify and quarantine all affected product in inventory. Customers should destroy and dispose of all affected product. If product was further distributed, distributors should identify their customers/consignees and notify them of the recall. The firm will provide replacement products once customer confirms destruction of affected product.