Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care
FDA device recall Z-0128-2007 · posted 2006-11-02 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Biological indicator failed. Investigation eliminated all equipment and product related factors.
- Action taken
- 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 for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 990 units
- Distribution
- Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand
- Date initiated
- 2006-09-27
- Date posted
- 2006-11-02
- Date terminated
- 2009-08-12
- Location
- Bannockburn, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHERIDAN/HVT,CF, UNCUFFED (K822082) | Sheridan Catheter Corp. | 1982-08-10 |