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U.S. Department of Health and Human Services

Class 2 Device Recall Shiley FlexTra

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  Class 2 Device Recall Shiley FlexTra see related information
Date Initiated by Firm December 09, 2004
Date Posted April 22, 2005
Recall Status1 Terminated 3 on January 18, 2006
Recall Number Z-0721-05
Recall Event ID 31273
510(K)Number K030787  
Product Classification Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal - Product Code JDH
Product 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.
Code Information All codes are affected.
Recalling Firm/
Manufacturer		 Nellcor Puritan Bennett
4280 Hacienda Dr
Pleasanton CA 94588-2719
For Additional Information Contact James Bonds
925-463-4371
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 323 units shipped to US Field Personnel or Healthcare facilities.
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JDH and Original Applicant = NELLCOR PURITAN BENNETT, INC.
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