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Terminated

Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.

FDA Recall Z-0927-03 · Posted 2003-06-12

Recalling FirmPortex, Inc
Recall StatusTerminated
Product CodeKOH
Date Initiated2003-02-20
Date Terminated2003-12-10
Product Quantity49

Reason for Recall

May have incorrectly printed graduation markings along the tube shaft.

Firm Action

A recall letter dated February 20, 2003 was issued to each customer. Customers were instructed to cease use of the lot and to return the product to Portex.

Root Cause

Other

Distribution Pattern

Nationwide, England and France

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K922665BIVONA HYPERFLEX TRACHEOSTOMY TUBEBivona Medical Technologies · 1993-01-07K894613BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBEBivona Medical Technologies · 1989-10-13K894614BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBEBivona Medical Technologies · 1989-10-13

Official Source

View FDA Recall →

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

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