Z-0112-2018 Class II Terminated
FDA device recall Z-0112-2018 was initiated by Medline Industries Inc on October 10, 2017 and is designated Class II. Reason for recall: Products labeled as sterile were distributed prior to sterilization The recall status is terminated (terminated August 4, 2020). Affected quantity: 190 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2017
- Initiation Date
- October 10, 2017
- Termination Date
- August 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units
Product Description
MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
Reason for Recall
Products labeled as sterile were distributed prior to sterilization
Distribution Pattern
FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras
Code Information
Lot 2861707008