Z-0760-2025 Class II Ongoing
FDA device recall Z-0760-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on November 12, 2024 and is designated Class II. Reason for recall: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. The recall status is ongoing. Affected quantity: 21,440 total.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2025
- Initiation Date
- November 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,440 total
Product Description
RUMMELL, Medline Item No. ST006ST
Reason for Recall
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI: 10653160251224 (ea) 00653160251227 (case); Lot 2023111490