Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, Fl
FDA device recall Z-0721-05 · posted 2005-04-22 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett
- Reason for recall
- Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
- Action taken
- On 12/3/04, the firm issued letters to all its international consignees, informing them of the affected product and providing instructions on the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDH
- Quantity affected
- 323 units shipped to US Field Personnel or Healthcare facilities.
- Distribution
- The firm has indicated that product was released for distribution to 7 consignees in US and to 17 foreign countries via international distribution centers. The firm has indicated that a very limited n
- Date initiated
- 2004-12-09
- Date posted
- 2005-04-22
- Date terminated
- 2006-01-18
- Location
- Pleasanton, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHILEY FLEXTRA TRACHEOSTOMY TUBE (K030787) | Nellcor Puritan Bennett, Inc. | 2003-11-14 |