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Terminated

Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.

FDA Recall Z-2911-2016 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDXE
Date Initiated2016-07-07
Date Terminated2017-10-25
Product Quantity2,425 catheters

Reason for Recall

Arrow is recalling due to incorrect labeling of products.

Firm Action

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 [email protected], 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.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K902327EMBOLECTOMY CATHETERClincal Instruments Corp. · 1991-02-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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