Recalls / —

—#163999

Product

Echogenic Needle; Product codes: PN-00215-E and PN-00217-E

FDA product code

FMI — Needle, Hypodermic, Single Lumen

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K071998

Affected lot / code info

Lot Numbers:  Product Codes PN-00215-E: 13F17J0072 13F17K0211 13F17L0700  Product code PN-00217-E: 13F17C0329 13F17E0118 13F17F0503 13F17G0093 13F17G0534 13F17H0383 13F17L0234

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 #163999. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.