FDAFDA · Food and drugs·Recall number Z-2659-2020
Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
Published July 29, 2020 · Recall initiated: May 28, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carefusion 2200 Inc
- Distributor
- 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.
- Lot
- Catalog: TPT1005SP UDI: 50885403220867; Batch: 0001345010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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