Safe-T-Centesis 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 6 Fr Catheter Drainage Tray due to a defect in the Universal Drainage Set (UDS) component. The UDS may contain valves that leak internally, which could allow 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 and Puerto Rico.
The recalled product carries catalog number PIG1260T and UDI 50885403108363. Affected batches include those numbered 0001319266 through 0001346480. The recall record does not specify a remedy or corrective action for affected consumers to 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: PIG1260T; UDI: 50885403108363; Batches: 0001319266, 0001320359, 0001320361, 0001321495, 0001321903, 0001322646, 0001323766, 0001324093, 0001324318, 0001331342, 0001332814, 0001332817, 0001333972, 0001335443, 0001335444, 0001335695, 0001336580, 0001336581, 0001336582, 0001336962, 0001336963, 0001337307, 0001337983, 0001338432, 0001338452, 0001339413, 0001339782, 0001339783, 0001341546, 0001342258, 0001342587, 0001343637, 0001343638, 0001344743, 0001346287, 0001346479, 0001346480
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.