Recall Z-1794-2024
Medtronic Perfusion Systems · initiated March 19, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic Clearview Blower/Mister, Model Number 22120
Codes / lots: GTIN 20643169888672, Lot Numbers: 2023040203, 2023040473
Reason for recall
Potential for unsealed sterile packing.
FDA-determined cause: Process control
Action taken
Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.
Details
- Recall number
- Z-1794-2024
- Initiated
- March 19, 2024
- Posted by FDA
- May 10, 2024
- Product code
- FQH – Lavage, Jet
- Quantity
- 500 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1793-2024 Class II | Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20…Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1795-2024 Class II | Medtronic DLP Coronary Ostial Cannulae, Model Number 30050Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1796-2024 Class II | Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1797-2024 Class II | Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012…Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1798-2024 Class II | Medtronic Tourniquet Sets: a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004…Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1799-2024 Class II | Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b)…Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1800-2024 Class II | Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root…Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1801-2024 Class II | Medtronic Cardioplegia Adapters: a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line…Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1802-2024 Class II | Medtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000…Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1803-2024 Class II | Medtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers:…Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1804-2024 Class II | Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number:…Potential for unsealed sterile packing. | 03/19/2024Open, Classified |
| Z-1805-2024 Class II | Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model…Potential for unsealed sterile packing. | 03/19/2024Open, Classified |