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Terminated

Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080

FDA Recall Z-0714-06 · Posted 2006-04-06

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeBTO
Date Initiated2006-03-07
Date Terminated2012-05-08
Product Quantity5350 units (107 cases)

Reason for Recall

Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm

Firm Action

Smiths Medical ASD, Inc. notified US customers by letter dated 3/7/06. Accounts are requested to return inventory.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030381PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULAPortex , Ltd. · 2003-08-27

Official Source

View FDA Recall →

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

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