Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
Check against the official notice below — it lists the full affected range.
CareFusion 2200 Inc. is recalling the Thora-Para 5 Fr Non-Valved Catheter Drainage Tray, specifically the Universal Drainage Set (UDS) component. The UDS may contain valves that leak internally, which could allow up to 30 cubic centimeters of air to enter a patient's body. The affected product was distributed to 370 U.S. customers and 13 distributors across all 50 states, Puerto Rico, and federally. The product is identified by catalog number OTP5000 and UDI 50885403284746, with 16 specific batch codes listed.
The recall notice does not specify a remedy or instructions for affected consumers regarding what action they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Reason for recall: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient. Distribution: 370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded. Quantity: N/A Lot/code info: Catalog: OTP5000; UDI: 50885403284746; Batches 0001319437, 0001320128, 0001321277, 0001321728, 0001322907, 0001324316, 0001332577, 0001334404, 0001335108, 0001336587, 0001337314, 0001338451, 0001339415, 0001341205, 0001342585, 0001344650, 0001346669, 0001346992
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.