Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-2012-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

TheraCath(R) Epidural Catheter; Product Code: EC-05000

Product Classification:

Class II

Date Initiated: April 11, 2018

Date Posted: June 6, 2018

Recall Number: Z-2012-2018

Event ID: 79890

Reason for Recall:

Product sterility may be compromised due to unsealed packaging.

Status: Terminated

Product Quantity: 416,055 total products

Code Information:

Lot Numbers: 13F17B0147 13F17C0176 13F17C0419 13F17E0464 13F17F0039 13F17F0498 13F17F0609 13F17F0789 13F17G0250 13F17J0076 13F17K0413 13F17K0414 13F17K0415 13F17K0416

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

Voluntary or Mandated:

Voluntary: Firm initiated