FDA recall Z-0112-2018
Medline Industries Inc · Class II · device
Product
MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
Reason for recall
Products labeled as sterile were distributed prior to sterilization
Distribution
FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras
Key facts
- Status
- Terminated
- Initiation date
- 2017-10-10
- Report date
- 2017-11-29
- Termination date
- 2020-08-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0112-2018