RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Check against the official notice below — it lists the full affected range.
Teleflex Medical Inc. is voluntarily recalling RUSCH Polaris laryngoscopes used to visualize the larynx during tracheal intubation. The recall affects approximately 157,150 units worldwide, including 156,980 units distributed across the United States and 170 units in Canada. The affected products are Model 44401, 44402, and 44403, with specific lot codes ranging from 197 through 20T, identified by their GTINs listed for individual units, boxes, and cases.
The recall was initiated because customers reported that the laryngoscope handles develop cracks and/or break at the hinge. The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
Reason for recall: Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. The country of Canada. Quantity: 157, 150 units (156,980 units in the US; 170 units OUS) Lot/code info: Model 44401 (GTIN: Each: 14026704662552 Box: 24026704662559 Case: 34026704662556; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20T); Model 44402 (GTIN: Each: 14026704662569 Box: 24026704662566 Case: 34026704662563; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20M, 20T); Model 44403 (GTIN: Each: 14026704662576 Box: 24026704662573 Case: 34026704662570; lots 197, 19A, 19F, 19J, 207, 20C, 20H, 20M, 20T).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.