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Recall Observatory FDA recall evidence

Device product

Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray

Z-2656-2020

May 28, 2020

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 85751
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2656-2020

Official wording

Reason: 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.

Code information: Catalog: TPT1000SP UDI: 50885403108431; Batches: 0001319836, 0001320129, 0001321726, 0001321727, 0001322906, 0001323275, 0001324091, 0001324317, 0001333308, 0001333777, 0001334187, 0001335697, 0001337779, 0001337982, 0001341544, 0001342586, 0001344739, 0001346286

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.