Z-2011-2018 Class II Terminated
FDA device recall Z-2011-2018 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
Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
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: 13F17B0039 13F17C0181 13F17D0226 13F17E0065 13F17E0724 13F17F0651 13F17G0531 13F17H0377 13F17J0273 13F17L0216 13F17L0218
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2011-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026