device · product 1 of 2
R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
- Recall number
- Z-0245-2016
- Initiated
- August 24, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Teleflex Medical
- Quantity
- 233,641 units
App-derived interpretation
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
Reason for recall
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.