Z-0246-2016Class II

Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical

Name: Z-0246-2016 Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical
Creator: Teleflex Medical
Published: 2015-08-24
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-08-24 / Terminated

FDA source

Teleflex Medical began a recall of Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical on 2015-08-24. FDA classified it as Class II and gives the reason as "Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0246-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-24
Posted: 2015-11-06
Terminated: 2017-09-25
Recalling firm: Teleflex Medical
Product: Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
Product code: BSR Stylet, Tracheal Tube
Reason for recall: Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.
FDA root cause: Unknown/Undetermined by firm
Action: 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 [email protected], 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.
Quantity in commerce: 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.
Product codes and lots: Material #503700-000060, Batch numbers: 13IG21, 13LG06, 14AG04, 14FG06, 14GG01, 14LG06, 15AG28, 15CG24 and 15DG38.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0246-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0245-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06
Z-0246-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06

Product code BSR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)