Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
Check against the official notice below — it lists the full affected range.
Carefusion 2200 Inc is recalling the Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection (Catalog TPT1005SDF) because the Universal Drainage Set (UDS) component may contain valves that leak internally, potentially allowing up to 30cc of air to enter a patient. The affected product was distributed to 370 US customers and 13 distributors across all 50 states and Puerto Rico, specifically in batches 0001333153 and 0001339557.
The recall record does not specify a remedy or recommended 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: TPT1005SDF UDI: 50885403228139; Batches: 0001333153 and 0001339557
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.