Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1961-2018)

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:

Epidural Needle; Product Codes: AN-05501 and AN-05505

Product Classification:

Class II

Date Initiated: April 11, 2018

Date Posted: June 6, 2018

Recall Number: Z-1961-2018

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: Product code AN-05501: 13F17A0211 13F17B0082 13F17C0378 13F17D0082 13F17E0023 13F17E0329 13F17E0838 13F17F0432 13F17F0813 13F17G0333 13F17H0059 13F17J0002 13F17L0598 Product code AN-05505: 13F17A0213 13F17C0109 13F17C0479 13F17E0208 13F17F0254 13F17F0727 13F17G0357 13F17J0161 13F17J0274 13F17L0441

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