Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
FDA Recall Z-2576-2018 · Posted None
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2018-05-23
Date Terminated2020-05-20
Product Quantity60 units
Reason for Recall
Product contains dry natural rubber latex. Label states Latex Free.
Firm Action
On May 23, 2018, Arrow International issued Urgent Medical Device Recall notices and response forms to their customer. Customers are advised to take the following actions:
1. Immediately discontinue distribution and quarantine affected product.
2. Using the provided customer letter and Recall Acknowledgement Form templates, customers who have further distributed product should contact those individuals.
3. To return affected products from your inventory, complete and return the Recall Acknowledgement Form via to 1-855-419-8507, Attn: Customer Service or email to [email protected].
4. If you and your customers have no affected stock, please complete and return the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected].
5. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Root Cause
Process control
Distribution Pattern
Puerto Rico
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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