Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
Check against the official notice below — it lists the full affected range.
Carefusion 2200 Inc. is recalling the Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray because the Universal Drainage Set (UDS) component may contain valves that leak internally, potentially allowing up to 30 cubic centimeters of air to enter a patient. The affected product was distributed to 370 U.S. customers and 13 distributors across all 50 states, Puerto Rico, and federally. The recalled item is catalog number TPT1000SP and affects 18 specific batch numbers.
The recall notice does not specify a remedy or recommend any particular action for consumers who may have this product.
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: TPT1000SP UDI: 50885403108431; Batches: 0001319836, 0001320129, 0001321726, 0001321727, 0001322906, 0001323275, 0001324091, 0001324317, 0001333308, 0001333777, 0001334187, 0001335697, 0001337779, 0001337982, 0001341544, 0001342586, 0001344739, 0001346286
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.