Recall Z-1793-2024
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 Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 87120; e) DLP Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222; f) DLP Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122; g) DLP Curved Tip Arterial Cannula 20 Fr., Model Number 87220; h) DLP Curved Tip Arterial Cannula 22 Fr., Model Number 87222; i) DLP" One-Piece Arterial Cannulae, Pediatric 6 Fr, Model Number 77006; j) DLP" One-Piece Pediatric Arterial Cannula 6 Fr, Model Number 77206; k) DLP" One-Piece Pediatric Arterial Cannula 8 Fr, Model Number 77008; l) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77010; m) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77110; n) DLP" One-Piece Pediatric Arterial Cannula 12 Fr, Model Number 77112; o) EOPA" Elongated One Piece Arterial Cannula 20 Fr., Model Number 77420; p) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77422; q) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77522; r) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77622; s) EOPA" Elongated One Piece Arterial Cannula 24 Fr., Model Number 77524; t) Select Series" Angled Tip Arterial Cannula 24Fr., Model Number 72424; u) Select Series" Straight Tip Arterial Cannula 20 Fr., Model Number 72120; v) Select Series" Straight Tip Arterial Cannula 24 Fr., Model Number 72224
Codes / lots: a) Model Number 80020, GTIN 20643169485703, Lot Numbers: 2023040597, 2023041061, 202305C247; b) Model Number 80220, GTIN 20643169485734, Lot Numbers: 2023031390, 2023040098, 202305C249, 202310C155; c) Model Number 82020, GTIN 20643169485536, Lot Numbers: 2023041063, 2023041396, 202305C253; d) Model Number 87120, GTIN 00673978187105, Lot Numbers: 2023040600; GTIN 20613994879114, Lot Numbers: 2023040600, 2023041066, 202306C018; e) Model Number 80222, GTIN 20643169485741, Lot Numbers: 2023041062, 202308C058; f) Model Number 87122, GTIN 00613994879103, Lot Numbers: 2023040601; GTIN 20613994879107, Lot Numbers: 2023040601, 2023041067, 202306C017; g) Model Number 87220, GTIN 00643169485563, Lot Numbers: 2023031282, 2023040602, 2023041068; GTIN 20643169485567, Lot Numbers: 2023031282, 2023031283, 2023031391, 2023040602, 2023041068, 202306C006, 202306C247; h) Model Number 87222, GTIN 00643169485570, Lot Numbers: 2023041408; GTIN 20643169485574, Lot Numbers: 2023041069, 2023041408, 202306C007; i) Model Number 77006, GTIN 20763000091013, Lot Numbers: 2023040943, 202306C056; j) Model Number 77206, GTIN 20763000091020, Lot Numbers: 2023041347, 202308C108; k) Model Number 77008, GTIN…
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-1793-2024
- Initiated
- March 19, 2024
- Posted by FDA
- May 10, 2024
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Quantity
- 13033 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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 |
| 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 |