Z-2012-2018 Class II Terminated
FDA device recall Z-2012-2018 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
TheraCath(R) Epidural Catheter; Product Code: EC-05000
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: 13F17B0147 13F17C0176 13F17C0419 13F17E0464 13F17F0039 13F17F0498 13F17F0609 13F17F0789 13F17G0250 13F17J0076 13F17K0413 13F17K0414 13F17K0415 13F17K0416
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2012-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026