Device product
MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
Z-0112-2018
Product summary
- Event
- Event 78319
- Status
- Terminated
- Classification
- Class II
- Quantity
- 190 units
- Official record key
device-enforcement:Z-0112-2018
Official wording
Reason: Products labeled as sterile were distributed prior to sterilization
Code information: Lot 2861707008
Distribution pattern: FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras
Derived failure modes
-
Unknown
Products labeled as sterile were distributed prior to sterilization