| Class 2 Device Recall Rsch FlexiSlip | |
Date Initiated by Firm | August 24, 2015 |
Date Posted | November 06, 2015 |
Recall Status1 |
Terminated 3 on September 25, 2017 |
Recall Number | Z-0245-2016 |
Recall Event ID |
72037 |
Product Classification |
Stylet, tracheal tube - Product Code BSR
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Product | Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical. |
Code Information |
Material #502501, Batch numbers: 12EE20, 12FE26, 12GE27, 12IE37, 12GE30, 13AG21, 12LG29, 12IE36, 12IE39, 13DG06, 12JE41, 12KE48, 13BG26, 13BG36, 13DG24, 14FG03, 14GG01, 14GG03, 14HE32, 14HE34, 14IE36, 14KG11, 14JG05, 14JE43, 14KG27, 14LG06, 15BG05, 15AG34, 15AG28, 15CG24, 15DE18, 15DG38, and 15EG08. |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr Research Triangle Park NC 27709-0186
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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 |
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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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