Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
FDA device recall Z-1557-2015 · posted 2015-04-30 · Terminated
Recall details
- Recalling firm
- Vital Signs Colorado Inc.
- Reason for recall
- Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
- Action taken
- Customers were notified on 3/13/15 via letter to perform an inventory, complete and return the Recall Response Form within 15 days, and to destroy the product on site (do not return to CareFusion).
- Root cause
- Packaging
- Status
- Terminated
- Product code
- BSR
- Quantity affected
- 399
- Distribution
- Worldwide Distribution. US Nationwide, Australia, Canada, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, South Korea, Lebanon, Mexico,
- Date initiated
- 2015-03-13
- Date posted
- 2015-04-30
- Date terminated
- 2015-10-07
- Location
- Englewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (K944729) | Coast Medical, Inc. | 1994-12-21 |