Recall Z-1805-2024
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 Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLP 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67316, h) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67516, i) DLP 18 Fr. Single Stage Venous Cannula, Model Number 66118, j) DLP 18 Fr. Single Stage Venous Cannula, Model Number 67318, k) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67320, l) DLP 20 Fr. Single Stage Venous Cannula, Model Number 69320, m) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67520, n) DLP 22 Fr. Single Stage Venous Cannula, Model Number 66122, o) DLP 22 Fr. Single Stage Venous Cannula, Model Number 67522, p) DLP 24 Fr. Single Stage Venous Cannula, Model Number 67524, q) DLP 26 Fr. Single Stage Venous Cannula, Model Number 67526, r) DLP 28 Fr. Single Stage Venous Cannula, Model Number 66128, s) DLP 28 Fr. Single Stage Venous Cannula, Model Number 39628, t) DLP 28 Fr. Single Stage Venous Cannula, Model Number 67528, u) DLP 30 Fr. Single Stage Venous Cannula, Model Number 66130, v) DLP 31 Fr. Single Stage Venous Cannula, Model Number 69331, w) DLP 32 Fr. Single Stage Venous Cannula, Model Number 66132, x) DLP 34 Fr. Single Stage Venous Cannula, Model Number 67534, y) DLP 36 Fr. Single Stage Venous Cannula, Model Number 66236, z) MC2 28/36 Fr. Two Stage Venous Cannula, Model Number 91228, aa) MC2 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C, bb) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263, cc) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C, dd) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C, ee) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246, ff) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C, gg) MC2 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C, hh) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251, ii) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C, jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438, kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C
Codes / lots: a) Model Number 68120, GTIN 20613994879435, Lot Numbers: 2023041436; b) Model Number 68124, GTIN 00613994879417, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 00681490466349, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 20613994879411, Lot Numbers: 2023041441, 2023041448, 202306C008; c) Model Number 68128, GTIN 00613994879394, Lot Numbers: 2023041040; c) Model Number 68128, GTIN 00681490466363, Lot Numbers: 2023041388; c) Model Number 68128, GTIN 20613994879398, Lot Numbers: 2023041040, 2023041388, 202306C010, 202306C011; d) Model Number 68130, GTIN 20613994879381, Lot Numbers: 2023041390, 202308C131; e) Model Number 68134, GTIN 20613994879367, Lot Numbers: 2023041431; f) Model Number 67312, GTIN 00613994879325, Lot Numbers: 2023041423; f) Model Number 67312, GTIN 00673978184180, Lot Numbers: 2023040074; f) Model Number 67312, GTIN 20613994879329, Lot Numbers: 2023040073, 2023040074, 2023041423; g) Model Number 67316, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; g) Model Number 67316, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; h) Model Number 67516, GTIN 00613994879301, Lot Numbers: 2023040076…
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-1805-2024
- Initiated
- March 19, 2024
- Posted by FDA
- May 10, 2024
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Quantity
- 17221 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-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 |