Home / Recalls / Cook Vascular Inc. / Z-1223-2018

Z-1223-2018 Class II Terminated

Recalled by Cook Vascular Inc. — Vandergrift, PA

FDA device recall Z-1223-2018 was initiated by Cook Vascular Inc. on November 28, 2017 and is designated Class II. Reason for recall: Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inser… The recall status is terminated (terminated October 3, 2018). Affected quantity: 31,006 Units.

Recall Details

Product Type: Devices
Report Date: April 4, 2018
Initiation Date: November 28, 2017
Termination Date: October 3, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 31,006 Units

Product Description

Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

Reason for Recall

Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port. This needle is used on the initial implant of the Vital-Port. Vital-Port products that have been successfully placed in patients are not impacted by this recall.

Distribution Pattern

The devices have been distributed within the United States and the following countries: United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Bulgaria, Bermuda, Brazil, Canada, Switzerland, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, Faroe Islands, France, United Kingdom, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Iceland, Italy, Jamaica, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Latvia, Morocco, Macedonia, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Serbia, Saudi Arabia, Sweden, San Marino, El Salvador, Turkey, Trinidad & Tobago, Ukraine, Uruguay, Venezuela, Virgin Islands, Kosovo, China, and South Africa.

Code Information

IPI, P-S