Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous recall
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic…
Why was Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous recalled?
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot Number: 13F19J0656 13F19K0368 13F19K0342 13F20C0596 13F20F0081 13F20F0229 13F20F0509 13F20F0578 13F20G0177 13F20G0566 13F20H0531 13F20J0379 13F20L0514 13F21A0354 13F21C0081 13F21C0749 13F21D0870 13F21E0415 13F21F1188
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic…
- Recalling firm
- Arrow International Inc
- Quantity
- 1918 units
- Distribution
- Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE CA CL CZ DE ES FR IL IT KR PH SA TR TW UK
- Recall date
- November 24, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)