Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
Check against the official notice below — it lists the full affected range.
Carefusion 2200 Inc is recalling the Safe-T-Centesis 6 Fr Catheter Drainage Tray without Lidocaine due to a defect in the Universal Drainage Set (UDS) component. The valves in the UDS may leak internally, potentially allowing up to 30 cubic centimeters of air to enter a patient during use. The affected product was distributed to 370 U.S. customers and 13 distributors across all 50 states, Puerto Rico, and other territories. The specific batches involved are 0001335833 and 0001341627, with catalog number PIG1260TCDF and UDI 50885403231894.
The recall notice does not specify a remedy or instructions for affected consumers regarding what action they should take.
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: PIG1260TCDF UDI: 50885403231894; Batches 0001335833 and 0001341627
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.