Class 1 Device Recall Shiley TracheoSoft

• Date Initiated by Firm: July 08, 2004
• Date Posted: August 07, 2004
• Recall Status: Terminated on November 29, 2005
• Recall Number: Z-1312-04
• Recall Event ID: 29653
• 510(K)Number: K003315
• Product Classification: unknown device name - Product Code ---
• Product: Shiley 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.
• 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: Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
• FDA Determined Cause: Other
• Action: On 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 Commerce: 71,021 units
• Distribution: The 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) Database: 510(K)s with Product Code = --- and Original Applicant = MALLINCKRODT, INC.