Recall Z-1223-2018— Cook Vascular Inc.

Name: FDA recall Z-1223-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-28

Class II · Terminated

Class II FDA medical device recall by Cook Vascular Inc., initiated 2017-11-28, terminated 2018-10-03. It names one FDA 510(k) clearance: K081425. Product: 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: 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..

Recalling firm: Cook Vascular Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-28
Terminated: 2018-10-03
Firm location: Vandergrift, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K081425 — COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORTCook Vascular, Inc.·cleared 2008-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.