Recalls / —

—#49045

Product

Portex Continuous Epidural tray Ref 4948-17

FDA product code

CAZ — Anesthesia Conduction Kit

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K965017

Affected lot / code info

Lot Number: 1063342

Why it was recalled

Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch

Root cause (FDA determination)

Other

Action the firm took

Smith Medical notified Dealers and direct customers contacted via letter delivered by Federal Express on October 27, 2006. Customers of dealers will be notified upon receipt of the dealer customer list.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern

Nationwide and Panama

Timeline

Recall initiated

2006-10-27

Posted by FDA

2006-11-22

Terminated

2012-05-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #49045. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.