Skip to content
Recall Observatory FDA recall evidence

Device product

Safe-T-Centesis 6 Fr Catheter Drainage Tray

Z-2648-2020

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-2648-2020

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: PIG1260T; UDI: 50885403108363; Batches: 0001319266, 0001320359, 0001320361, 0001321495, 0001321903, 0001322646, 0001323766, 0001324093, 0001324318, 0001331342, 0001332814, 0001332817, 0001333972, 0001335443, 0001335444, 0001335695, 0001336580, 0001336581, 0001336582, 0001336962, 0001336963, 0001337307, 0001337983, 0001338432, 0001338452, 0001339413, 0001339782, 0001339783, 0001341546, 0001342258, 0001342587, 0001343637, 0001343638, 0001344743, 0001346287, 0001346479, 0001346480

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.