# FDA recall Z-1223-2018

> **Cook Vascular Inc.** · Class II · device recall initiated 2017-11-28.

## 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 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

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.

## Key facts

- **Recall number:** Z-1223-2018
- **Recalling firm:** Cook Vascular Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-28
- **Report date:** 2018-04-04
- **Termination date:** 2018-10-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vandergrift, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1223-2018

## Citation

> AI Analytics. FDA recall Z-1223-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1223-2018. Source: US FDA. Licensed CC0.

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