FDAClass IINovember 18, 2015

R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft recall

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

Why was R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
Recalling firm
Teleflex Medical
Quantity
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.
Recall date
November 18, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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