Thora-Para 8 Fr Catheter Drainage Tray
Check against the official notice below — it lists the full affected range.
Carefusion 2200 Inc. has recalled the Thora-Para 8 Fr Catheter Drainage Tray (catalog TPT1000) due to a defect in the Universal Drainage Set valves. The valves may 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 states and Puerto Rico.
The recall affects specific batches of the product, identified by batch numbers ranging from 0001319053 through 0001346671. 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: TPT1000 UDI: 50885403108486; Batches: 0001319053, 0001319438, 0001320227, 0001320514, 0001321276, 0001321497, 0001322638, 0001322905, 0001323536, 0001323775, 0001332576, 0001334403, 0001334406, 0001335268, 0001335696, 0001336965, 0001338449, 0001338788, 0001338789, 0001339414, 0001339562, 0001341206, 0001341633, 0001342263, 0001343223, 0001343636, 0001344137, 0001346668, 0001346670, 0001346671
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.