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Terminated

Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed, Tyco Healthcare/Nellcor is currently responsible for Research and Development for this product. Tyco Healthcare/MMJ S.A. De C.V., Cuidad Juarez, Mexico manufactures the FlexTra Tracheostomy Tube. The product is sterilized at Sterigenics, located at Santa Teresa, New Mexico.

FDA Recall Z-0721-05 · Posted 2005-04-22

Recalling FirmNellcor Puritan Bennett
Recall StatusTerminated
Product CodeJDH
Date Initiated2004-12-09
Date Terminated2006-01-18
Product Quantity323 units shipped to US Field Personnel or Healthcare facilities.

Reason for Recall

Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.

Firm Action

On 12/3/04, the firm issued letters to all its international consignees, informing them of the affected product and providing instructions on the recall.

Root Cause

Other

Distribution Pattern

The firm has indicated that product was released for distribution to 7 consignees in US and to 17 foreign countries via international distribution centers. The firm has indicated that a very limited number of the product was distributed in the US to selected facilities that were participating in customer preference testing, after the device had received 510(k) clearance and all remaining stock was collected and returned to the company. Tyco Healthcare/Nellcor shipped Tyco Healthcare affiliate offices outside of the US. Foreign distribution include: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Holland, Italy, Norway, Poland, Singapore, Spain, Sweden, Switzerland and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030787SHILEY FLEXTRA TRACHEOSTOMY TUBENellcor Puritan Bennett, Inc. · 2003-11-14

Official Source

View FDA Recall →

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

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