URGENT MEDICAL DEVICE RECALL

March 11, 2010

Recall Product List »

Recall Acknowledgement Form »

Arrow International Inc. (“Arrow”) has issued a voluntary worldwide recall for ALL lots of Arrow Walrus intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters (see Recall Product List). This recall was issued in three separate notifications to customers on February 5, 19, and 23, 2010.

Testing revealed pin holes in some of the pouches in which the products are packaged, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death.

Arrow International has notified the United States Food and Drug Administration (FDA) and other health authorities of this recall.

Consumers who have any of the following product should STOP using and take the following actions:

1. If you have no affected stock, please indicate so on the Recall Acknowledgement Form and fax to Arrow International’s fax number: 800-343-2935.
2. If you do have stock, please contact Arrow’s Customer Service IV Tubing hotline at 866-396-2111 for a Return Authorization Number. Once you have received the Return Authorization Number, please enter it in the space provided on the Recall Acknowledgement & Stock Status Form.
3. Complete the Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International, Fax number: 800-343-2935, Attn: Customer Service. This will allow us to document your receipt of this letter and the amount of product you have on hand for return.
4. Return any affected product freight collect, along with the original completed Recall Acknowledgement & Stock Status Form to the following:
• Arrow International, Inc.
• 312 Commerce Place
• Asheboro, NC 27203
• Attn: Asheboro Quality Assurance Manager


5. Arrow International can credit your account when the product is returned.

No injuries have been reported to date however significant under-reporting of adverse events may have occurred.

We sincerely apologize for any disruptions this action may cause to your operation. Arrow International remains committed to providing high quality, safe and effective products. If you require additional information or clarification regarding this matter, please contact Arrow International, Customer Service Department at 800-523-8446.