Z-2294-2023 Class II Ongoing
FDA device recall Z-2294-2023 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: 192 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
- 192 kits
Product Description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
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
Model Number: DYNJ45158A, UPC Number: 088827750721, all lot numbers distributed from Medline between 04/01/2020 and 04/28/2023.