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U.S. Department of Health and Human Services

Class 1 Device Recall Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless

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 Class 1 Device Recall Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cufflesssee related information
Date Initiated by FirmMay 08, 2015
Date PostedJuly 09, 2015
Recall Status1 Terminated 3 on April 12, 2017
Recall NumberZ-1950-2015
Recall Event ID 71197
510(K)NumberK142298 
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
ProductShiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF,3.5NCF,4.0NCF,4.5NCF,2.5PCF,3.0PCF,3.5PCF,4.0PCF,4.5PCF,5.0PCF,5.5PCF,5.0PLCF,5.5PLCF,6.0PLCF,6.5PLCF,3.0NEF-P,3.5NEF-P,4.0NEF-P,4.5NEF-P,3.0PEF-P,3.5PEF-P,4.0PEF-P,4.5PEF-P,5.0PEF-P,5.5PEF-P,
Code Information All products manufactured since 2/2012. Including All lot numbers beginning with 12, 13 and 14.
Recalling Firm/
Manufacturer		 Covidien LP (formerly Nellcor Puritan Bennett Inc.)
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information ContactMr. Michael A. Ronningen
303-876-8870
Manufacturer Reason
for Recall		Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.
FDA Determined
Cause 2		Device Design
ActionConsignees were notified 5/8/15 via letter. Consignees were asked to return products.
Quantity in Commerce69,461 units total
DistributionWorldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JOH
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