Syntel Silicone Thrombectomy Catheter recall
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Why was Syntel Silicone Thrombectomy Catheter recalled?
The guide tip can become damaged and result in the tip detaching.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item No. A4545, A4548, A4554, A4558, A4568; GTIN: 840663109807, 840663109838, 840663109814, 840663109821, 840663109845; Lot No: SST1004, SST1005, SST1006, SST1007, SST1009, SST1010, SST1013, SST1018, SST1019, SST1020, SST1021, SST1022, SST1023, SST1024, SST1025, SST1026, SST1027, SST1028, SST1029, SST1030, SST1031, SST1032, SST1033, SST1034, SST1035, SST1036, SST1037, SST1038, SST1041, SST1042, SST1043, SST1044, SST1045, SST1046, SST1047, SST1048, SST1049, SST1050, SST1051, SST1054, SST1055, SST1056, SST1057, SST1058, SST1059, SST1060, SST1061, SST1062, SST1063, SST1064, SST1065, SST1066, SST1067, SST1068, SST1071.
- Product
- Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 5,604 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.
- Recall date
- May 22, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)