Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with
FDA device recall Z-2243-2016 · posted 2016-07-19 · Terminated
Recall details
- Recalling firm
- Parker Medical
- Reason for recall
- Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.
- Action taken
- Customers were notified on June 2, 2016 that a recall was initiated via telephone. The information communicated identified the affected product, problem and actions to be taken. Customers were instructed to segregate the affected product for immediate pick-up. A Sales Representatives went to each hospital and retrieved all unused product.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 5,500 units
- Distribution
- US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.
- Date initiated
- 2016-06-02
- Date posted
- 2016-07-19
- Date terminated
- 2017-01-31
- Location
- Highlands Ranch, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL (K110269) | Well Lead Medical Co., Ltd. | 2011-08-26 |