Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patie
FDA device recall Z-0582-05 · posted 2005-03-10 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.
- Action taken
- The direct accounts were notified of the mislabeling by letter dated 1/14/05, sent via Federal Express, Next Business Day Delivery on the same date. The accounts were requested to return their inventories of the affected lot to Teleflex Medical/Hudson RCI, and to subrecall the lot from their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 8,990 units
- Distribution
- Nationwide
- Date initiated
- 2005-01-14
- Date posted
- 2005-03-10
- Date terminated
- 2005-08-19
- Location
- Bannockburn, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHERIDAN/HVT,CF, UNCUFFED (K822082) | Sheridan Catheter Corp. | 1982-08-10 |