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Terminated

Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.

FDA Recall Z-1667-2013 · Posted 2013-07-08

Recalling FirmBryan Medical Inc
Recall StatusTerminated
Product CodeBTO
Date Initiated2013-04-17
Date Terminated2013-10-29
Product Quantity5 units

Reason for Recall

The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

Firm Action

The consignees were contacted by telephone and asked to return the recalled product.

Root Cause

Labeling Change Control

Distribution Pattern

Distributed in KY and AL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K893866HOOD PEDIATRIC TRACHEOSTOMY TUBEHood Laboratories · 1989-08-07

Official Source

View FDA Recall →

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

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