Device product
Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Z-0063-2022
Product summary
- Event
- Event 88671
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 bundles
- Official record key
device-enforcement:Z-0063-2022
Official wording
Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Code information: All Lots
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND.
Derived failure modes
-
Unknown
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing