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U.S. Department of Health and Human Services

Class 2 Device Recall Rsch FlexiSlip

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  Class 2 Device Recall Rsch FlexiSlip see related information
Date Initiated by Firm August 24, 2015
Date Posted November 06, 2015
Recall Status1 Terminated 3 on September 25, 2017
Recall Number Z-0246-2016
Recall Event ID 72037
Product Classification Stylet, tracheal tube - Product Code BSR
Product Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
Code Information Material #503700-000060, Batch numbers: 13IG21, 13LG06, 14AG04, 14FG06, 14GG01, 14LG06, 15AG28, 15CG24 and 15DG38.
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Jennifer E. Suh
610-378-0131 Ext. 60347
Manufacturer Reason
for Recall		 Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Consignees were notified by letter on 08/24/2015. They were instructed to immediately discontinue use and quarantine any products with the listed catalog numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax or e-mail to recalls@teleflex.com, even if they do not have any of the affected stock. Distributors were instructed to communicate the recall to any of their customers who have received the affected product and to have the customers return any affected product to them with the completed Recall Acknowledgement Form.
Quantity in Commerce 233,641 units
Distribution Worldwide Distribution -- U.S. Nationwide; International Distribution: Argentina, Austria, Belgium, Belgrade, Cameroon, Canada, Chile, Costa Rica, Croatia, Czech Republic, Ecuador, Denmark, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guyana, Hong Kong, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Martinique, Netherlands, Panama, Peru, Poland, Portugal, Reunion, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Venezuela, and the United Arab Emirates.
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.
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