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U.S. Department of Health and Human Services

Class 1 Device Recall Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube

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  Class 1 Device Recall Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube see related information
Date Initiated by Firm January 14, 2009
Date Posted March 04, 2009
Recall Status1 Terminated 3 on May 21, 2012
Recall Number Z-0997-2009
Recall Event ID 51160
510(K)Number K945513  
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
Product Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as one each shipped in an inner carton to end customers.

The intended use of the device is to bypass upper airway obstructions, provide long term ventilation, and support and/or manage tracheal/bronchial secretions.
Code Information Lot Numbers: 0806000266, 0806000858, 0806000859, 0806001328, 0807000555, 0807001444, 0807002502, 0808000387, 0808000431, 0808002285, 0810000288, 0810000289, 0810000864, 0810000865, 0810001201, 0811000228, 0811000522, 0811000523, 0811000546, 0811000547 and 0811001875.
Recalling Firm/
Manufacturer		 Covidien Limited
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information Contact
800-635-5267 Ext. 1
Manufacturer Reason
for Recall		 Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube.
FDA Determined
Cause 2		 Finished device change control
Action Consignees were sent an "Urgent Device Alert" letter dated 01/14/2009, by mail via Federal Express overnight delivery and instructed to evaluate any of the affected lot numbers of tracheostomy tubes prior to placement into a patient's stoma. If either the obturator or the desired sterile suction catheter does not fit properly into the tube, the tube must not be inserted into the patient. Further instructions are available at Nellcor Technical Services by calling 1-800-635-5267, option 3, then option 1. New product was expected by mid February, 2009, to address the issue.
Quantity in Commerce 8,931 units
Distribution Nationwide Distribution, including Puerto Rico.
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 = JOH and Original Applicant = MALLINCKRODT MEDICAL
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