Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free
Check against the official notice below — it lists the full affected range.
CareFusion 2200 Inc. is recalling the Safe-T 8 Fr Thora-Para Tray with 8 Fr. Catheter and Sharps Injury Protection due to a defect in the Universal Drainage Set (UDS). 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 product was distributed to approximately 370 US customers and 13 distributors across all 50 states, Puerto Rico, and other territories. The affected product has catalog number TPT1000SDF and the recalled batches are identified by the following lot codes: 0001320515, 0001321729, 0001323273, 0001323703, 0001332819, 0001334405, 0001338453, 0001344142, and 0001344740.
The recall record does not specify a remedy or instructions for affected consumers.
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: TPT1000SDF UDI: 50885403108493; Batches: 0001320515, 0001321729, 0001323273, 0001323703, 0001332819, 0001334405, 0001338453, 0001344142, 0001344740
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.