Skip to content
Recall Observatory FDA recall evidence

Device product

REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.

Z-0812-2016

January 04, 2016

Class III

Product summary

Firm
C.R. Bard, Inc.
Event
Event 72977
Status
Terminated
Classification
Class III
Quantity
15,400 units
Official record key
device-enforcement:Z-0812-2016

Official wording

Reason: Report by a customer of an open package seal.

Code information: Lot Number NGZE1190

Distribution pattern: US Nationwide Distribution - in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    open package