FDA Recall Terminated

Extension Line Slide Clamps; Product codes: SA-09847

Recall: Z-2030-2018 · Initiated April 11, 2018

Recall

Recall Number
Z-2030-2018
Event Number
79890
Firm
Arrow International Inc
FEI Number
3015859709
Product Code
KGZ
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
April 11, 2018
Terminated
May 15, 2020
Address
2400 Bernville Rd, Reading, PA, 19605-9607

Description

Extension Line Slide Clamps; Product codes: SA-09847

Reason

Product sterility may be compromised due to unsealed packaging.

Action

On April 11, 2018 Arrow International mailed Urgent Medical Device Recall notifications to affected customers. Customers were instructed to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter. Customers with questions may contact your local sales representative or Customer Service at (866)246-6990.

Distribution

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

Quantity

416,055 total products