—#181971

Product

Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

FDA product code: PXI — Thoracentesis Tray
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Catalog: OTP5000; UDI: 50885403284746; Batches 0001319437, 0001320128, 0001321277, 0001321728, 0001322907, 0001324316, 0001332577, 0001334404, 0001335108, 0001336587, 0001337314, 0001338451, 0001339415, 0001341205, 0001342585, 0001344650, 0001346669, 0001346992

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

All affected consignees are being notified via FedEx mailed letter and/or email beginning 6/15/2020. BD requests a sub-recall to be conducted if product has been further distributed. Consignees are asked to complete the acknowledgement form included with the notification letter and return to BD.

Recalling firm

Firm: Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-05-28
Terminated: 2024-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.