Z-1223-2018Class II

Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S

Name: Z-1223-2018 Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S
Creator: Cook Vascular Inc.
Published: 2017-11-28
License: https://open.fda.gov/license/

Cook Vandergrift, Inc. / initiated 2017-11-28 / Terminated / root cause: manufacturing process

FDA source

Cook Vascular Inc. began a recall of Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use... on 2017-11-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1223-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-28
Posted: 2018-03-27
Terminated: 2018-10-03
Recalling firm: Cook Vandergrift, Inc.
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.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Removal for all non-expired lots of the Cook Vital-Port Vascular Access System. Written recall communication letters will be mailed via courier to US Consignees.plan to STORE recalled product(s)? (if returned) Recalled products will be returned to global regional distribution warehouses to be quarantined in a marked receiving area of returned goods. 8.9 Provide plan for final DISPOSITION for recalled product(s)? All recalled products will be destroyed at the regional distribution warehouses. A certificate of destruction will be provided upon completion of destruction prior to the completion of the recall. Products remaining in the control of Cook will be assessed for rework to replace the non-coring needle.
Quantity in commerce: 31,006 Units
Distribution: 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.
Product codes and lots: IPI, P-S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1223-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1223-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27

Product code LJT

K081425Class IICook Vascular Inc. Vital-Port Vascular Access System Power Injectable PortCook Vascular, Inc. / cleared 2008-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)