Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1975-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM

Product Classification:

Class II

Date Initiated: April 11, 2018

Date Posted: June 6, 2018

Recall Number: Z-1975-2018

Event ID: 79890

Reason for Recall:

Product sterility may be compromised due to unsealed packaging.

Status: Terminated

Product Quantity: 416,055 total products

Code Information:

Lot Numbers: 13F17A0258 13F17D0075 13F17G0275 13F17L0615

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

Voluntary or Mandated:

Voluntary: Firm initiated