Z-2017-2018 Class II Terminated
FDA device recall Z-2017-2018 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
Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS
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: Product Code MSO-29802-AHS: 13F17C0408 13F17E0419 13F17F0683 13F17H0283 13F17K0545 Product Code MSO-29903-AHS: 13F17E0607 13F17G0356 13F17K0327 13F17L0350
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2017-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026