Recalls / —

—#163840

Product

Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418

FDA product code

DQY — Catheter, Percutaneous

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K810962

Affected lot / code info

Lot Numbers:  Product code AN-04320: 13F17A0131,13F17B0101,13F17B0320,13F17D0234, 13F17F0242,13F17H0488,13F17J0454,13F17M0003 Product code AN-04418: 13F17F0738 and 13F17J0445

Why it was recalled

Product sterility may be compromised due to unsealed packaging.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 recalls@teleflex.com. 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 recalls@teleflex.com. 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.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern

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

Timeline

Recall initiated

2018-04-11

Terminated

2020-05-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #163840. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.