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Recall Observatory FDA recall evidence

Device product

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

Z-0245-2016

August 24, 2015

Class II

Product summary

Firm
Teleflex Medical
Event
Event 72037
Status
Terminated
Classification
Class II
Quantity
233,641 units
Official record key
device-enforcement:Z-0245-2016

Official wording

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

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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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