Recalls / —

—#39087

Product

Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm Product Number: 535080

FDA product code

JOH — Tube Tracheostomy And Tube Cuff

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K031057

Affected lot / code info

Lot Numbers: K515073, K515074, K515075, K518076, K518077, K520176, K523556, K527903, K548745, K559483, K614996, K630177

Why it was recalled

Guiding catheter may have thinner and weaker sidewalls than designed, and may break.

Root cause (FDA determination)

Other

Action the firm took

Smith Medical ASD initiated recall by letter on/about about May 16, 2005.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern

Natiowide Foreign: Canada, Mexico and East Timor.

Timeline

Recall initiated

2005-05-16

Posted by FDA

2005-06-04

Terminated

2012-05-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #39087. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.