Z-2013-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 6, 2018
- Initiation Date
- April 11, 2018
- Termination Date
- May 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 416,055 total products
Product Description
0.2 Micron Flat Epidural Filter; Product Code: EF-05500
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: 13F17D0240 13F17G0371 13F17K0408