Z-0517-2012

Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex...

Name: Z-0517-2012 Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex...
Creator: Teleflex Medical
Published: 2011-12-02
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2011-12-02 / Terminated

FDA source

Teleflex Medical began a recall of Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600... on 2011-12-02. The reason FDA records is "Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0517-2012
Status: Terminated
Initiated: 2011-12-02
Posted: 2012-01-11
Terminated: 2014-04-29
Recalling firm: Teleflex Medical
Product: Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Product code: BSR Stylet, Tracheal Tube
Reason for recall: Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received.
FDA root cause: Pending
Action: The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" letter dated December 2, 2011 to its Consignees/Customers. The letter described the product, problem and actions to be take. The customers were instructed to immediately discontinue use and quarantine any products with the listed catalog and lot numbers; return the product; complete and return the enclosed Immediate Attention Requested Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service (a customer service representative will contact the customer with a returns good authorization number and provide instructions for the return of product to Teleflex medical), even if they have no affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 73,281 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada and Europe.
Product codes and lots: Catalog numbers: 502501, Lot numbers: 10JG05, 10JG28, 10JG35, 10JG42, 10KG07, 10KG30, 10KE48, 10LG22, 10LG25, 11AG02, 11AG25, 11GE07, 11BG11, 11BE08, 11BE09, 11CG16, 11CG19, 11DE15, 11EE30, 11EE21, 11FE24, 11GE29, 11GE30 and 11GG41.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)