Recall Z-0517-2012 ยท BSR Stylet, Tracheal Tube
Teleflex Medical
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.
| Date | Jan 11, 2012 (initiated Dec 2, 2011) |
| Status | Terminated |
| Reason | Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received. |
| 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 a |
| Quantity | 73,281 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Canada and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.