Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 7.0mm Product Number: 538070E
FDA Recall Z-0870-05 · 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.