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.
FDA Recall Z-0517-2012 · Posted 2012-01-11
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBSR
Date Initiated2011-12-02
Date Terminated2014-04-29
Product Quantity73,281 units
Reason for Recall
Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received.
Firm 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.
Root Cause
Pending
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Canada and Europe.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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