FDA recall Z-0113-2018

Medline Industries Inc · Class II · device

Product

MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile

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-0113-2018