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Terminated

Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,ID 7.0mm Product Number: 535070

FDA Recall Z-0867-05 · Posted 2005-06-04

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeJOH
Date Initiated2005-05-16
Date Terminated2012-05-08

Reason for Recall

Guiding catheter may have thinner and weaker sidewalls than designed, and may break.

Firm Action

Smith Medical ASD initiated recall by letter on/about about May 16, 2005.

Root Cause

Other

Distribution Pattern

Natiowide Foreign: Canada, Mexico and East Timor.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KITPortex, Inc. · 2003-07-18

Official Source

View FDA Recall →

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

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