Recalls / —
—#149374
Product
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
- FDA product code
- DXE — Catheter, Embolectomy
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K902327
- Affected lot / code info
- Lot/Batch 14F15H0292, 14F15J0139, 14F15A0174, CF3016366, 14F14E0300, 14F15G0349, 14F15H0261, CF2079921, 14F15J0363, 14F14J0155, 14F15F0406, 14F15E0263, 14F15H0258, 14F15H0251, 14F15G0347. CF2125865, 14F15D0197, 14F15H0025, 14F15H0332, 14F15B0244, 14F15G0348
Why it was recalled
Arrow is recalling due to incorrect labeling of products.
Root cause (FDA determination)
Component design/selection
Action the firm took
The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated July 07, 2016 via FedEx to its customers. The letter described the product, problems and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any products they may have on hand; return product, and complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com, even if you have no affected stock. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Recalling firm
- Firm
- Arrow International Inc
- Address
- 2400 Bernville Rd, Reading, Pennsylvania 19605-9607
Distribution
- Distribution pattern
- US Nationwide Distribution
Timeline
- Recall initiated
- 2016-07-07
- Terminated
- 2017-10-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #149374. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.