Recall Z-0127-2007 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical
Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22210
| Date | Nov 2, 2006 (initiated Sep 27, 2006) |
| Status | Terminated |
| Reason | Biological indicator failed. Investigation eliminated all equipment and product related factors. |
| Root cause | Other |
| Action | Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned |
| Quantity | 830 units |
| Distribution | Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822082 | SHERIDAN/HVT,CF, UNCUFFED Sheridan Catheter Corp., Aug 10, 1982 |