Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0113-2018

October 10, 2017

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 78319
Status
Terminated
Classification
Class II
Quantity
120 units
Official record key
device-enforcement:Z-0113-2018

Official wording

Reason: Products labeled as sterile were distributed prior to sterilization

Code information: Lot 28617070015

Distribution pattern: FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products labeled as sterile were distributed prior to sterilization