Recall Z-1801-2024
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 Cardioplegia Adapters: a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G, f) DLP Perfusion/Venting Adapter, Model Number 13002, g) DLP Y Adapter Coronary Perfusion, Model Number 10710
Codes / lots: a) Model Number 25009, GTIN 20613994918608, Lot Numbers: 2023040212, 202305C110; b) Model Number 25010, GTIN 20613994918585, Lot Numbers: 2023041227, 202305C111; c) Model Number 14003, GTIN 00613994619662, Lot Numbers: 2023040464; c) Model Number 14003, GTIN 20613994619666, Lot Numbers: 2023040463, 2023040464, 202305C102; d) Model Number 14000, GTIN 00613994619716, Lot Numbers: 2023041205, 2023041206; d) Model Number 14000, GTIN 20613994619710, Lot Numbers: 2023041205, 2023041206, 202305C098, 202305C099; e) Model Number 11001G, GTIN 00613994918550, Lot Numbers: 2023031005; e) Model Number 11001G, GTIN 20613994918554, Lot Numbers: 2023030371, 2023030659, 2023031004, 2023031005, 2023031530, 2023040160, 2023040431, 2023040432, 2023040804, 2023040805, 2023041171, 202306C131, 202306C136, 202308C218; f) Model Number 13002, GTIN 20613994756057, Lot Numbers: 2023040459, 202305C097; g) Model Number 10710, GTIN 20613994685937, Lot Numbers: 20613994685937
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-1801-2024
- Initiated
- March 19, 2024
- Posted by FDA
- May 10, 2024
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Quantity
- 6290 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-1794-2024 Class II | Medtronic Clearview Blower/Mister, Model Number 22120Potential 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-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 |