Z-2705-2024 Class II Ongoing
FDA device recall Z-2705-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 22, 2024 and is designated Class II. Reason for recall: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. The recall status is ongoing. Affected quantity: 2588 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 28, 2024
- Initiation Date
- Mar 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2588 units
Product Description
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
Reason for Recall
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Distribution Pattern
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Code Information
a) REF DYK1012268E1, UDI/DI 40884389919089 (case), 10884389919088 (unit), Lot Numbers: 22FBU931, 22HBL619, 22JBG192, 22LBH957, 23CBU467, 23FBS319, 23IBT789, 23KMH977
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2705-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026