Recall Z-0569-04 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD, Inc.
PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080
| Date | Jul 20, 2004 (initiated Dec 12, 2003) |
| Status | Terminated |
| Reason | Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm |
| Root cause | Other |
| Action | 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. |
| Quantity | 30 CASES (2/CASE) |
| Distribution | AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980466 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA Sims Portex, Inc., Feb 24, 1998 |