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Terminated

BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.

FDA Recall Z-0587-04 · Posted 2004-07-20

Recalling FirmBecton Dickinson Infusion Therapy
Recall StatusTerminated
Product CodeFOZ
Date Initiated2004-02-03
Date Terminated2004-06-10
Product Quantity12000 units

Reason for Recall

Splittable catheter introducer may not fully split or may separate non-uniformly.

Firm Action

On 02/03/2004, all consignees were notified by telephone and letter.

Root Cause

Other

Distribution Pattern

Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974764INTROSYTE CATHETERBecton Dickinson Infusion Therapy Systems, Inc. · 1998-02-26

Official Source

View FDA Recall →

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

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