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Terminated

Premicath 28G PICC Catheter

FDA Recall Z-0090-06 · Posted 2005-10-28

Recalling FirmVygon Corporation
Recall StatusTerminated
Product CodeLJS
Date Initiated2005-06-27
Date Terminated2005-10-31
Product Quantity243 units

Reason for Recall

Guidewire protuding from tip of the catheter

Firm Action

The recalling firm issued a recall letter via fax to the distributors on 6/27/05. The letter informed the distributors of the problem and to notify any hospital accounts of the problem and the need to trim the catheter prior to implantation.

Root Cause

Other

Distribution Pattern

The product was shipped to distributors in CA, CO, FL, IL, MD, NJ, NY, OH, PA, TX and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041468PREMICATH, 1261.205Vygon Corp. · 2004-09-09

Official Source

View FDA Recall →

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

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