Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-2028-2018)

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:

VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP

Product Classification:

Class II

Date Initiated: April 11, 2018
Date Posted: June 6, 2018
Recall Number: Z-2028-2018
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: 13F17A0119 13F17D0019 13F17D0130 13F17D0186 13F17D0278 13F17E0113 13F17F0193 13F17F0480 13F17G0074 13F17G0329 13F17G0506 13F17H0536 13F17J0208 13F17K0438

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