Date Initiated by Firm | May 23, 2018 |
Create Date | July 30, 2018 |
Recall Status1 |
Terminated 3 on May 20, 2020 |
Recall Number | Z-2576-2018 |
Recall Event ID |
80378 |
510(K)Number | K780532 |
Product Classification |
Percutaneous Sheath Introducer Kit - Product Code DYB
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Product | 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. |
Code Information |
Lot/Batch Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019 |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
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For Additional Information Contact | Karen Boylan 866-396-2111 |
Manufacturer Reason for Recall | Product contains dry natural rubber latex. Label states Latex Free. |
FDA Determined Cause 2 | Process control |
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 recalls@teleflex.com.
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 recalls@teleflex.com.
5. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111. |
Quantity in Commerce | 60 units |
Distribution | Puerto Rico |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DYB
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