Recall Z-0245-2016 ยท BSR Stylet, Tracheal Tube
Teleflex Medical
Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
| Date | Nov 6, 2015 (initiated Aug 24, 2015) |
| Status | Terminated |
| Reason | Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. |
| 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 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. |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.