Z-1975-2018 Class II Terminated
FDA device recall Z-1975-2018 was initiated by Arrow International Inc on Apr 11, 2018 and is designated Class II. Reason for recall: Product sterility may be compromised due to unsealed packaging. The recall status is terminated (terminated May 15, 2020). Affected quantity: 416,055 total products.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 6, 2018
- Initiation Date
- Apr 11, 2018
- Termination Date
- May 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 416,055 total products
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
Reason for Recall
Product sterility may be compromised due to unsealed packaging.
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
Code Information
Lot Numbers: 13F17A0258 13F17D0075 13F17G0275 13F17L0615
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1975-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026