Safe-T PLUS Thora-Para 5 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 5 Fr Catheter Drainage Tray because the Universal Drainage Set (UDS) component may contain valves that leak internally. This internal valve leakage could allow up to 30 cubic centimeters of air to be introduced into the patient. The affected product has catalog number TPT1005SP and UDI 50885403220867, batch 0001345010.
The product was distributed to 370 U.S. customers and 13 distributors across all 50 states, Puerto Rico, and other territories. The recall record does not specify a remedy or recommended action 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: TPT1005SP UDI: 50885403220867; Batch: 0001345010
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.