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Terminated

Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.

FDA Recall Z-0338-06 · Posted 2006-01-06

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeBTO
Date Initiated2005-04-19
Date Terminated2007-12-06
Product Quantity11

Reason for Recall

The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.

Firm Action

Consignee was notified via recall letter dated April 19, 2005.

Root Cause

Other

Distribution Pattern

California, Indiana and North Carolina.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K922665BIVONA HYPERFLEX TRACHEOSTOMY TUBEBivona Medical Technologies · 1993-01-07

Official Source

View FDA Recall →

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

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