Z-0152-2025 Class II Ongoing
FDA device recall Z-0152-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on September 4, 2024 and is designated Class II. Reason for recall: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is open… The recall status is ongoing. Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2024
- Initiation Date
- September 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kit
Reason for Recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Code Information
UDI/DI 40193489967273 (each), 10193489967272 (case), , Lot Numbers: 23KBQ236