Safe-T-Centesis PLUS 6 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 6 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 has catalog number PIG1260TSP and UDI 50885403108387, and involves ten specific batch numbers: 0001319377, 0001321496, 0001324092, 0001333971, 0001335442, 0001336583, 0001336964, 0001338981, 0001343845, 0001344649, and 0001346293.
The product was distributed to 370 U.S. customers and 13 distributors across all 50 states, Puerto Rico, and the District of Columbia. The source does not specify a remedy or what affected consumers should do.
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: PIG1260TSP UDI: 50885403108387; Batches: 0001319377, 0001321496, 0001324092, 0001333971, 0001335442, 0001336583, 0001336964, 0001338981, 0001343845, 0001344649, 0001346293
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.