Safe-T-Centesis PLUS 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-Centesis PLUS 8 Fr Catheter Drainage Tray because the Universal Drainage Set (UDS) may contain valves that leak internally, potentially allowing up to 30 cubic centimeters of air to enter a patient. The affected product has catalog number PIG1280TSP and UDI 50885403108424, with six specific batch numbers: 0001320865, 0001321079, 0001333154, 0001333780, 0001335440, 0001338450, and 0001341635.
The product was distributed to 370 U.S. customers and 13 distributors across all 50 states, as well as Puerto Rico. The recall source does not specify a remedy or corrective 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: PIG1280TSP UDI: 50885403108424; Batches: 0001320865, 0001321079, 0001333154, 0001333780, 0001335440, 0001338450, 0001341635
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.