Recalls / —

—#42996

Product

4954-16 Portex Epidural Mini-pack

FDA product code

CAZ — Anesthesia Conduction Kit

Device class

Class 2

Medical specialty

Anesthesiology

Affected lot / code info

Lot Numbers: K171983, K189454, K204089, K221871, K504917, K508494, K515834, K519834, K522275, K525643, K529958, K547910, K549185, K629253, K632933, K636834, K643593, K645615, K655989, K656463

Why it was recalled

Tray may contain holes compromising the sterility of the device

Root cause (FDA determination)

Other

Action the firm took

Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2005-11-17

Posted by FDA

2005-11-30

Terminated

2012-05-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #42996. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.