Z-2327-2023 Class II Ongoing
FDA device recall Z-2327-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on May 15, 2023 and is designated Class II. Reason for recall: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. The recall status is ongoing. Affected quantity: 144 kits.
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- May 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 kits
Product Description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-FLAP HARVEST PACK, Model Number: DYNJ58575C
Reason for Recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Code Information
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ58575C, UPC Number: 019532714414.