Device product
R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
Z-0245-2016
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
Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.