Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged Clean -Non-S
FDA device recall Z-0265-2010 · posted 2009-11-16 · Terminated
Recall details
- Recalling firm
- Sharn, Inc.
- Reason for recall
- Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
- Action taken
- Recalling firm is contacting all direct accounts (distributors & user facilities) by telephone and letter. They request completion and return of the of the Return Goods Form and of any affected product by UPS using the firm's account number.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CCT
- Quantity affected
- 300
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-03-05
- Date posted
- 2009-11-16
- Date terminated
- 2012-07-13
- Location
- Tampa, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOPICAL APPLICATOR (K070596) | Sharn, Inc. | 2007-06-21 |