Z-3128-2024 Class II Ongoing
FDA device recall Z-3128-2024 was initiated by Medtronic Perfusion Systems on Jul 9, 2024 and is designated Class II. Reason for recall: During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model… The recall status is ongoing. Affected quantity: 290 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- Jul 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 290 units
Product Description
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Reason for Recall
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.
Code Information
GTIN 20613994879329, Lot Numbers: 2023090954, 202312C065
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3128-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026