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Terminated

Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter

FDA Recall Z-2191-2008 · Posted 2008-09-17

Recalling FirmCook Vascular Inc.
Recall StatusTerminated
Product CodeLJT
Date Initiated2008-04-24
Date Terminated2008-09-18
Product Quantity20 units

Reason for Recall

mislabeled - wrong size catheter was packaged in the box

Firm Action

The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.

Root Cause

Packaging process control

Distribution Pattern

The products were shipped to distributors in Japan and Brazil.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K924748VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112PMed Institute, Inc. · 1993-07-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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