PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080
FDA device recall Z-0569-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm
- Action taken
- Smiths Medical contacted dealers via telephone on December 12, 2003. The direct customers to whom product was shipped contacted via a visit by the Smiths Medical sales representative Monday, December 15, 2003 through December 12,2 003.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 30 CASES (2/CASE)
- Distribution
- AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI
- Date initiated
- 2003-12-12
- Date posted
- 2004-07-20
- Date terminated
- 2006-05-02
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (K980466) | Sims Portex, Inc. | 1998-02-24 |