Recalls / —

—#139626

Product

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

FDA product code

BSR — Stylet, Tracheal Tube

Device class

Class 1

Medical specialty

Anesthesiology

Affected lot / code info

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.

Why it was recalled

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

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Consignees were notified by letter on 08/24/2015. They were instructed to immediately discontinue use and quarantine any products with the listed catalog numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax or e-mail to recalls@teleflex.com, even if they do not have any of the affected stock. Distributors were instructed to communicate the recall to any of their customers who have received the affected product and to have the customers return any affected product to them with the completed Recall Acknowledgement Form.

Recalling firm

Firm

Teleflex Medical

Address

2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

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.

Timeline

Recall initiated

2015-08-24

Posted by FDA

2015-11-06

Terminated

2017-09-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #139626. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.