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Terminated

Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***.

FDA Recall Z-0496-03 · Posted 2003-01-30

Recalling FirmSorenson Medical, Inc.
Recall StatusTerminated
Product CodeBSY
Date Initiated2002-11-25
Date Terminated2004-07-12
Product Quantity2790 units

Reason for Recall

Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated.

Firm Action

On 10/25/2002, all consignees were notified by letter.

Root Cause

Other

Distribution Pattern

Distributors in IL, OH, PA. Foreign distribution to Brazil, Czech Republic, Denmark, Guatemala, Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961707TRACH-EZE CLOSED VENTILATION SUCTION SYSTEMSorenson Critical Care · 1997-03-11

Official Source

View FDA Recall →

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

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