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
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
open package