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U.S. Department of Health and Human Services

Class 1 Device Recall Shiley TracheoSoft

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 Class 1 Device Recall Shiley TracheoSoftsee related information
Date Initiated by FirmJuly 08, 2004
Date PostedAugust 07, 2004
Recall Status1 Terminated 3 on November 29, 2005
Recall NumberZ-1312-04
Recall Event ID 29653
510(K)NumberK003315 
Product Classification unknown device name - Product Code ---
ProductShiley TracheoSoft XLT Extended Length Tracheostomy tube; Model Numbers: 72110-050, size 5, Proximal Extension, Uncuffed; 72110-060, size 6, Proximal Extension, Uncuffed; 72110-070, size 7, Proximal Extension, Uncuffed; 72110-080, size 8, Proximal Extension, Uncuffed; 72120-050, size 5, Promixal Extension, Cuffed; 72120-060, size 6, Promixal Extension, Cuffed; 72120-070, size 7, Promixal Extension, Cuffed; 72120-080, size 8, Promixal Extension, Cuffed; 73110-050, size 5, Distal Extension, Uncuffed; 73110-060, size 6, Distal Extension, Uncuffed; 72110-070, size 7, Distal Extension, Uncuffed; 73110-080, size 8, Distal Extension, Uncuffed; 73120-050, size 5, Distal Extension, Cuffed; 73120-060, size 6, Distal Extension, Cuffed; 73120-070, size 7, Distal Extension, Cuffed; 73120-080, size 8, Distal Extension, Cuffed; 77100-050, size 5 XLT Disposal Inner Cannula; 77100-060, size 6 XLT Disposal Inner Cannula; 77100-070, size 7 XLT Disposal Inner Cannula; 77100-080, size 8 XLT Disposal Inner Cannula Manufactured by Mallinckrodt Medical, County Westmeath Cornamaddy, Athlone, Ireland; Customer Service: Mallinckrodt, Inc. St Louis, MO 63134
Code Information All units of these models.
FEI Number 2936999
Recalling Firm/
Manufacturer		 Nellcor Puritan Bennett
4280 Hacienda Dr
Pleasanton CA 94588-2719
For Additional Information ContactJames Bonds
925-463-4371
Manufacturer Reason
for Recall		Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
FDA Determined
Cause 2		Other
ActionOn 7/8/04, the firm initiated the recall. ***[After CDRH recommendations for class I recall situation, the firm issued PR via AP on 8/6/04.]*** .
Quantity in Commerce71,021 units
DistributionThe tracheostomy tubes were distributed to 4,179 direct US and US Territory customers. The firm has also distributed products to Canada, the UK, Latin America and Japan. The firm's branches in those countries are handling the recall activities in those countries. The firm manufactured 95,923 units and distributed 71.021 throughout the US and US territories. 4,481 are on hold at the Nellcor distribution facility, and approximately 3000 units are currently in distribution.
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) Database510(K)s with Product Code = ---
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