Recalls / —

—#30846

Product

PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080

FDA product code

JOH — Tube Tracheostomy And Tube Cuff

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K980466

Affected lot / code info

Lot Number: K223373

Why it was recalled

Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern

AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI

Timeline

Recall initiated

2003-12-12

Posted by FDA

2004-07-20

Terminated

2006-05-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #30846. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.