PlainRecalls
FDA Devices Moderate Class II Terminated

R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.

Reported: November 18, 2015 Initiated: August 24, 2015 #Z-0245-2016

Product Description

R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.

Reason for Recall

Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.

Details

Recalling Firm
Teleflex Medical
Units Affected
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.
Location
Research Triangle Park, NC

Frequently Asked Questions

What product was recalled?
R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.. Recalled by Teleflex Medical. Units affected: 233,641 units.
Why was this product recalled?
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 18, 2015. Severity: Moderate. Recall number: Z-0245-2016.