Safe-T-Centesis 8 Fr Catheter Drainage Tray
Check against the official notice below — it lists the full affected range.
The Universal Drainage Set (UDS) component of the Carefusion 2200 Inc Safe-T-Centesis 8 Fr Catheter Drainage Tray may contain valves that leak internally, potentially allowing 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 other territories.
The recalled product has catalog number PIG1280T and UDI 50885403108400, with affected batch numbers 0001320864, 0001321078, 0001333781, 0001335698, 0001336588, 0001337539, 0001341632, and 0001345260. The source document 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: PIG1280T UDI: 50885403108400; Batches: 0001320864, 0001321078, 0001333781, 0001335698, 0001336588, 0001337539, 0001341632, 0001345260
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.